T-tube drainage versus primary closure after laparoscopic common bile duct exploration

  • Conclusions changed
  • Review
  • Intervention

Authors


Abstract

Background

T-tube drainage may prevent bile leak from the biliary tract following bile duct exploration and it offers post-operative access to the bile ducts for visualisation and exploration. Use of T-tube drainage after laparoscopic common bile duct (CBD) exploration is controversial.

Objectives

To assess the benefits and harms of T-tube drainage versus primary closure after laparoscopic common bile duct exploration.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until April 2013.

Selection criteria

We included all randomised clinical trials comparing T-tube drainage versus primary closure after laparoscopic common bile duct exploration.

Data collection and analysis

Two of four authors independently identified the studies for inclusion and extracted data. We analysed the data with both the fixed-effect and the random-effects model meta-analyses using Review Manager (RevMan) Analysis. For each outcome we calculated the risk ratio (RR), rate ratio (RaR), or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis.

Main results

We included three trials randomising 295 participants: 147 to T-tube drainage versus 148 to primary closure. All trials had a high risk of bias. No one died during the follow-up period. There was no significant difference in the proportion of patients with serious morbidity (17/147 (weighted percentage 11.3%) in the T-tube drainage versus 9/148 (6.1%) in the primary closure group; RR 1.86; 95% CI 0.87 to 3.96; three trials), and no significant difference was found in the serious morbidity rates (weighted serious morbidity rate = 97 events per 1000 patients) in participants randomised to T-tube drainage versus serious morbidity rate = 61 events per 1000 patients in the primary closure group; RR 1.59; 95% CI 0.66 to 3.83; three trials). Quality of life was not reported in any of the trials. The operating time was significantly longer in the T-tube drainage group compared with the primary closure group (MD 21.22 minutes; 95% CI 12.44 minutes to 30.00 minutes; three trials). The hospital stay was significantly longer in the T-tube drainage group compared with the primary closure group (MD 3.26 days; 95% CI 2.49 days to 4.04 days; three trials). According to one trial, the participants randomised to T-tube drainage returned to work approximately eight days later than the participants randomised to the primary closure group (P < 0.005).

Authors' conclusions

T-tube drainage appears to result in significantly longer operating time and hospital stay as compared with primary closure without any evidence of benefit after laparoscopic common bile duct exploration. Based on currently available evidence, there is no justification for the routine use of T-tube drainage after laparoscopic common bile duct exploration in patients with common bile duct stones. More randomised trials comparing the effects of T-tube drainage versus primary closure after laparoscopic common bile duct exploration may be needed. Such trials should be conducted with low risk of bias, assessing the long-term beneficial and harmful effects including long-term complications such as bile stricture and recurrence of common bile duct stones.

摘要

背景

比較腹腔鏡總膽管結石取石術之後以初步縫合或以對照TTUBE引流術之比較

人們對腹腔鏡膽總管探查之後實施TTUBE引流術的做法一直存有爭議。我們不能找到針對腹腔鏡膽總管探查之後實施TTUBE引流術的利弊而實施的統合分析或系統性文獻回顧

目標

評估在腹腔鏡總膽管結石取石術之後常規實施初步縫合或以TTUBE引流術之比較。

搜尋策略

我們搜尋截至2006年1月前的The Cochrane HepatoBiliary Group Controlled Trials Register ,Cochrane Library的Cochrane Central Register of Controlled Trials (CENTRAL) 、MEDLINE、EMBASE和Science Citation Index Expanded。

選擇標準

我們收錄所有在腹腔鏡總膽管探查術之後比較初步縫合(含有或不含有膽道支架)或TTUBE引流術的隨機臨床試驗。

資料收集與分析

我們從一個找到已確定的試驗中收集有關試驗特性,方法學品質、死亡率、發病率、手術時間和住院日數等資料。我們使用RevMan分析軟體以固定效果模式分析資料。對於每個結果(outcome),我們根據治療意向,計算odds ratio,(OR)和加權平均差(weighted mean difference,WMD)及95%信賴區間。

主要結論

共包括1個試驗,隨機分配 55 位病人: 27 人被分配到初步縫合組,28人被分配到TTUBE組。本次試驗的方法學品質並不恰當。各個小組沒有提到死亡率,除了住院日數 (WMD −2.8 天, 95% CI −1.93 3.67)以外,初步縫合組的住院日較短。兩個小組對任何結果都沒有統計上顯著差異。

作者結論

我們沒有足夠的證據建議腹腔鏡總膽管結石探查術之後TTUBE引流術優於初步縫合,反之亦然。 需要實施進一步的隨機試驗來評估腹腔鏡總膽管探查術之後實施TTUBE引流術對照初步縫合的利弊。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

初步縫合看似和腹腔鏡總膽管探查術之後實施的TTUBE引流術同樣有效。觀察研究對於腹腔鏡總膽管探查取石術之後實施TTUBE引流術卻得出互相矛盾的結果。 只有一個隨機試驗在腹腔鏡總膽管取石術之後比較初步縫合(27 位病人) 和TTUBE引流術 (28 位病人) ,但是研究方法品質不適當。TTUBE引流術組和無膽道支架的初步縫合組,除住院日數以外,在任何結果上沒有顯示有統計上顯著差異。仍需要實施進一步的隨機試驗來評估腹腔鏡總膽管探查術之後實施TTUBE引流術對照初步縫合的利弊。

Résumé scientifique

Drainage par tube T versus fermeture primaire après une exploration laparoscopique du canal cholédoque

Contexte

Le drainage avec un tube T peut prévenir les fuites de bile du canal biliaire après une exploration du canal biliaire et il offre un accès post-opératoire sur les voies biliaires pour la visualisation et l'exploration. L'utilisation du drainage avec un tube T après une exploration laparoscopique du canal cholédoque est controversée.

Objectifs

Evaluer les bénéfices et les inconvénients du drainage avec un tube T par rapport à une fermeture primaire après une exploration laparoscopique du canal cholédoque.

Stratégie de recherche documentaire

Nous avons effectué une recherche dans le registre Cochrane des essais contrôlés (CENTRAL) dans The Cochrane Library, ainsi que dans MEDLINE, EMBASE et Science Citation Index Expanded jusqu'à avril 2013.

Critères de sélection

Nous avons inclus tous les essais cliniques randomisés comparant le drainage avec un tube T à une fermeture primaire après une exploration laparoscopique du canal cholédoque.

Recueil et analyse des données

Deux des quatre auteurs ont indépendamment identifié les études à inclure et extrait les données. Nous avons analysé les données avec des méta-analyses à effets fixes et à effets aléatoires en utilisant l'analyse Review Manager (RevMan). Pour chaque résultat, nous avons calculé le risque relatif (RR), le taux de proportion ou la différence moyenne (DM) avec des intervalles de confiance (IC) à 95% sur la base de l'analyse en intention de traiter.

Résultats principaux

Nous avons inclus trois essais randomisant 295 participants : 147 avec un drainage avec tube T et 148 avec une fermeture primaire. Tous les essais présentaient un risque élevé de biais. Aucun participant n'est décédé pendant la période de suivi. Nous n'avons pas constaté de différence significative dans le pourcentage de patients avec une morbidité grave (17/147 (pourcentage moyen 11,3 %) dans le groupe avec drainage avec tube T et 9/148 (6,1 %) dans le groupe avec fermeture primaire ; RR 1,86 ; IC à 95 % 0,87 à 3,96 ; trois essais) et aucune différence significative n'a été constatée dans les taux de morbidité grave (taux de morbidité grave moyen = 97 évènements sur 1000 patients) chez les participants randomisés dans le groupe avec drainage avec tube T par rapport au taux de morbidité grave = 61 évènements sur 1000 patients dans le groupe avec fermeture primaire ; RR 1,59 ; IC à 95 % 0,66 à 3,83 ; trois essais). Aucun essai ne rendait compte de la qualité de vie. La durée de l'opération était bien plus longue dans le groupe avec un drainage avec tube T par rapport au groupe avec fermeture primaire (DM 21,22 minutes ; IC à 95 % 12,44 à 30,00 minutes ; trois essais). L'hospitalisation était bien plus longue dans le groupe avec un drainage avec tube T par rapport au groupe avec fermeture primaire (DM 3,26 jours ; IC à 95 % 2,49 jours à 4,04 jours ; trois essais). Selon un essai, les participants randomisés avec un drainage avec tube T ont repris le travail environ huit jours après les participants randomisés avec une fermeture primaire (P <0,005).

Conclusions des auteurs

Le drainage avec un tube T semble entraîner une durée d'opération et d'hospitalisation bien plus longue par rapport à la fermeture primaire sans preuve apparente de bénéfice sur les résultats cliniquement importants après une exploration laparoscopique du canal cholédoque. En se basant sur les données actuellement disponibles, rien ne justifie l'utilisation systématique du drainage avec un tube T après une exploration laparoscopique du canal cholédoque chez les patients avec des calculs dans le canal cholédoque. Des essais randomisés complémentaires comparant les effets du drainage avec un tube T à la fermeture primaire après une exploration laparoscopique du canal cholédoque peuvent être nécessaires. Ces essais devront être réalisés avec un faible risque de biais et évaluer les effets bénéfiques et nocifs à long terme du drainage avec un tube T, y compris les complications à long terme comme la sténose biliaire et la récidive des calculs dans le canal cholédoque.

Plain language summary

T-tube drainage versus primary closure after laparoscopic common bile duct exploration

The liver has various functions. Production of bile is one of these functions. Bile is necessary for digestion of fat and removal of certain waste byproducts from the liver. The bile produced in the liver is stored temporarily in the gallbladder. On eating fatty food, the gallbladder releases the bile into the small bowel. The common bile duct is the tube through which bile flows from the gallbladder to the small bowel. Stones can obstruct the flow of bile from the gallbladder into the small bowel. Usually such stones are formed in the gallbladder and migrate into the common bile duct. Obstruction to the flow of bile can lead to jaundice. Such stones are usually removed by inserting an endoscope (introducing an instrument equipped with a camera through the mouth and into the small intestine) before keyhole removal of gallstones (laparoscopic cholecystectomy), or as a part of keyhole removal of gallstones (laparoscopic common bile duct exploration). Laparoscopic common bile duct exploration can only be performed in highly specialised centres and so endoscopic removal of the common bile duct stone is the commonly used method to treat stones in the common bile duct. Laparoscopic common bile duct exploration involves exploring the common bile duct using instruments or a camera, or both, which are introduced into the common bile duct usually through a cut in the common bile duct. After the stones are removed, the hole in the common bile duct has to be stitched. Traditionally, surgeons have used a T-tube through the cut in the common bile duct but they seal the cystic duct if the exploration is performed through the cystic duct. The T-tube is shaped like the English letter 'T' as the name indicates. The top part of the letter 'T' is inside the common bile duct while the long bottom part of the 'T' is brought out of the tummy through a small cut and connected to a bag. This tube is inserted with the intention of preventing the build-up of bile in the common bile duct due to temporary swelling, which is common after any cut in any part of the body. The build-up of bile along with the swelling can potentially prevent the healing of the bile duct resulting in a leakage of bile from the common bile duct into the tummy. Uncontrolled bile leak can be potentially life-threatening if this is not recognised and treated appropriately. In addition to acting as a drain, which drains the bile from the common bile duct to the exterior, dye can be injected into the T-tube and an X-ray used to demonstrate any residual stones. Once the absence of residual stones is confirmed, the T-tube is removed. However, surgeons are concerned about the tiny hole which the T-tube leaves on removal. This tiny hole in the common bile duct normally heals without a trace but, in some patients, bile can leak through this hole and cause the very problem that the T-tube was meant to prevent. Thus, the use of a T-tube after laparoscopic common bile duct exploration is a very controversial issue. We have attempted to answer the question whether T-tube drainage is better than primary closure (stitching the cut in the bile duct without a T-tube) after laparoscopic exploration of common bile duct by reviewing all the available information from randomised clinical trials that is in the literature. Randomised clinical trials are a special type of clinical study which provides the most accurate answer if performed correctly.

We identified a total of three trials including 295 participants, of whom 148 were randomly chosen to receive primary closure and the remaining patients had T-tube drainage after laparoscopic exploration of common bile duct. All three trials were at high risk of bias (risk of underestimating or overestimating the benefits and harms of the intervention). There were no deaths in either group. There was no significant difference in the serious complication rate (approximately 97 complications per 1000 patients in the T-tube group versus 61 complications per 1000 participants in the primary closure group) or in the proportion of participants who developed serious complications (11.3% in the T-tube group versus 6.2% in the primary closure group). Although the complication rates in the T-tube group appear to be twice as high as those in the primary closure group, there is a possibility that this was not a true observation but rather a difference that occurred by chance (similar to there being one chance in eight of flipping a coin and having it come up heads or tails four times in a row). For this reason, we cannot be sufficiently confident scientifically that these differences were not just due to chance and that is the reason why we have stated that there was no 'significant' difference. Of course, if such a difference truly exists, it would be clinically important. None of the trials reported the quality of life of the participants. The average operating time was significantly longer in the T-tube group than in the primary closure group (by about 20 minutes). The average hospital stay was significantly longer in the T-tube group than in the primary closure group (by about three days). Participants returned to work significantly later in the T-tube group than primary closure group (by about eight days). Use of T-tube appears to increase the cost without providing any benefit to the patients. Further randomised trials with low risk of bias (low chance of arriving at wrong conclusions because of prejudice by healthcare providers, researchers, or patients) with longer follow-up period are necessary. Until the results from such trials are available, we discourage the routine use of T-tube after laparoscopic common bile duct exploration.

Résumé simplifié

Drainage par tube T versus fermeture primaire après une exploration laparoscopique du canal cholédoque

Le foie a de nombreuses fonctions. La production de la bile est l'une de ces fonctions. La bile est nécessaire pour digérer les lipides et supprimer certains déchets du foie. La bile produite dans le foie est stockée temporairement dans la vésicule biliaire. Lorsque l'on mange des aliments gras, la vésicule biliaire libère de la bile dans l'intestin grêle. Le canal cholédoque est le tube dans lequel circule la bile entre la vésicule biliaire et l'intestin grêle. Les calculs peuvent obstruer l'écoulement de la bile entre la vésicule biliaire et l'intestin grêle. Généralement, ces calculs se forment dans la vésicule biliaire et migrent dans le canal cholédoque. L'obstruction de l'écoulement de la bile peut entraîner une jaunisse. Ces calculs sont généralement enlevés à l'aide d'un endoscope (en introduisant un instrument équipé d'une caméra dans la bouche ou dans l'intestin grêle) avant d'enlever les calculs par laparoscopie (cholécystectomie laparoscopique) ou dans le cadre d'une ablation laparoscopique des calculs biliaires (exploration laparoscopique du canal cholédoque). L'exploration laparoscopique du canal cholédoque ne peut être réalisée que dans des centres très spécialisés, l'ablation endoscopique des calculs du canal cholédoque est donc la méthode la plus fréquemment utilisée pour traiter les calculs du canal cholédoque. L'exploration laparoscopique du canal cholédoque implique d'explorer le canal cholédoque à l'aide d'instruments ou d'une caméra, ou les deux, qui sont introduits dans le canal cholédoque généralement via une incision dans celui-ci. Une fois les calculs enlevés, l'incision du canal cholédoque doit être suturée. Habituellement, les chirurgiens utilisent un tube T qu'ils insèrent dans l'incision du canal cholédoque mais ils obturent le canal cystique si l'exploration est réalisée par le canal cystique. Le tube T a la forme de la lettre 'T', comme son nom l'indique. La partie supérieure de la lettre 'T' se situe à l'intérieur du canal cholédoque alors que la partie basse ressort de l'abdomen par une petite incision et est raccordée à un sac. Ce tube est inséré dans le but de prévenir le développement de bile dans le canal cholédoque dû à un œdème temporaire, ce qui est courant après une incision dans quelque partie du corps que ce soit. La formation de bile et l'œdème peuvent potentiellement empêcher la cicatrisation du canal biliaire et entraîner une fuite de bile du canal cholédoque dans l'abdomen. Une fuite de bile incontrôlée dans la cavité abdominale peut menacer le pronostic vital si elle n'est pas reconnue et traitée de manière appropriée. En plus d'agir comme un drain, qui draine la bile du canal cholédoque vers l'extérieur, un colorant peut être injecté dans le tube T et les rayons X peuvent être utilisés pour démontrer qu'il ne reste pas de calculs. Une fois l'absence de calculs résiduels confirmée, le tube T est enlevé. Pour autant, les chirurgiens sont préoccupés par ce petit orifice que laisse le tube T lorsqu'on le retire. Ce minuscule trou dans le canal cholédoque cicatrise normalement sans laisser de trace, mais chez certains patients, il peut y avoir une fuite de bile par cet orifice et cela peut entraîner le problème que le tube T était censé prévenir. Ainsi, l'utilisation d'un tube T après une exploration laparoscopique du canal cholédoque est très controversée. Nous avons essayé de répondre à cette question et de savoir si le drainage avec un tube T donne de meilleurs résultats que la fermeture primaire (suturer l'incision dans le canal biliaire sans tube-T) après une exploration laparoscopique du canal cholédoque en examinant toutes les informations disponibles dans les essais cliniques randomisés présents dans la littérature. Les essais cliniques randomisés sont un type spécifique d'études cliniques qui apportent les réponses les plus précises s'ils sont bien réalisés.

Nous avons identifié trois essais totalisant 295 participants, dont 148 étaient choisis de manière aléatoire pour recevoir une fermeture primaire et les patients restants pour recevoir un drainage avec un tube T après une exploration laparoscopique du canal cholédoque. Les trois essais présentaient un risque de biais élevé (risque de sous-estimer ou surestimer les avantages et les inconvénients de l'intervention). Il n'y a eu aucun décès dans l'un ou l'autre des groupes. Nous n'avons pas constaté de différence significative dans le taux de complications graves (environ 97 complications sur 1000 patients dans le groupe avec tube T et 67 complications sur 1000 participants dans le groupe avec fermeture primaire) ou dans le pourcentage de participants qui ont développé des complications graves (11,3 % dans le groupe avec tube T et 6,2 % dans le groupe avec fermeture primaire). Bien que les taux de complications dans le groupe avec tube T semblaient être deux fois plus élevés que ceux du groupe avec fermeture primaire, il est possible que cette observation ne soit pas vérifiée, mais plutôt une différence survenue par hasard (similaire au fait d'avoir une chance sur huit de lancer une pièce et qu'elle se retrouve du côté pile ou du côté face quatre fois de suite). Pour cette raison, nous sommes dans l'impossibilité scientifique de démontrer que ces différences n'étaient pas simplement dues au hasard et c'est la raison pour laquelle nous avons indiqué qu'il n'y avait pas de différence 'significative'. Bien évidemment, si une telle différence existe, elle serait cliniquement importante. Aucun des essais ne rendait compte de la qualité de vie des patients. La durée moyenne de l'intervention était bien plus longue dans le groupe avec tube T que dans le groupe avec fermeture primaire (d'environ 20 minutes). La durée moyenne de l'hospitalisation était bien plus longue dans le groupe avec tube T que dans le groupe avec fermeture primaire (d'environ 3 jours). Les participants ont repris le travail bien plus tard dans le groupe avec tube T que dans le groupe avec fermeture primaire (d'environ huit jours). L'utilisation d'un tube T semble accroître les coûts sans apporter de bénéfice pour les patients. Il est indispensable de réaliser des essais randomisés supplémentaires avec un risque de biais faible (faible chance d'arriver à de mauvaises conclusions en raison du préjudice sur les prestataires de santé, les chercheurs ou les patients) sur une période de suivi plus longue. Jusqu'à ce que les résultats de ces essais soient disponibles, nous décourageons l'utilisation d'un tube T après une exploration laparoscopique du canal cholédoque.

Notes de traduction

Traduit par: French Cochrane Centre 7th August, 2013
Traduction financée par: Pour la France : Minist�re de la Sant�. Pour le Canada : Instituts de recherche en sant� du Canada, minist�re de la Sant� du Qu�bec, Fonds de recherche de Qu�bec-Sant� et Institut national d'excellence en sant� et en services sociaux.

Summary of findings(Explanation)

Summary of findings for the main comparison. T-tube drainage compared to primary closure after laparoscopic common bile duct exploration
  1. 1 All the trials were at high risk of bias.
    2 There were few trials included in this review and reporting bias could not be assessed.
    3 There was moderate heterogeneity.
    4 The confidence intervals include 1 and either 0.75 or 1.25 or both.

T-tube drainage compared to primary closure after laparoscopic common bile duct exploration
Patient or population: laparoscopic common bile duct exploration.
Settings: secondary or tertiary hospital.
Intervention: T-tube drainage.
Comparison: primary closure.
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Assumed riskCorresponding risk
Primary closure T-tube drainage
Serious morbidity (rate) 61 per 1000 97 per 1000
(40 to 233)
Rate ratio 1.59
(0.66 to 3.83)
295
(3 studies)
⊕⊝⊝⊝
very low 1,2,3,4
Serious morbidity (proportion of patients) 61 per 1000 113 per 1000
(53 to 241)
RR 1.86
(0.87 to 3.96)
295
(3 studies)
⊕⊝⊝⊝
very low 1,2,3,4
Operating time
(minutes)
The mean operating time in the control groups was
106.48 minutes
The mean operating time in the intervention groups was
21.22 minutes higher
(12.44 to 30 higher)
 295
(3 studies)
⊕⊝⊝⊝
very low 1,2
Hospital stay
(days)
The mean hospital stay in the control groups was
3.93 days
The mean hospital stay in the intervention groups was
3.26 days higher
(2.49 to 4.04 higher)
 295
(3 studies)
⊕⊝⊝⊝
very low 1,2
*The basis for the assumed risk is the overall control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

About 5% to 25% of the adult western population have gallstones (GREPCO 1984; GREPCO 1988; Bates 1992; Halldestam 2004). The annual incidence of gallstones is about 1 in 200 people (NIH 1992). Only 2% to 4% of people with gallstones become symptomatic with biliary colic (pain), acute cholecystitis (inflammation), obstructive jaundice, or gallstone pancreatitis in a year (Attili 1995; Halldestam 2004). Cholecystectomy (removal of gallstones) is the preferred option in the treatment of symptomatic gallstones (Strasberg 1993) and every year, 1.5 million cholecystectomies are performed in the United States and 60,000 in the United Kingdom (Dolan 2009; HES 2011). Approximately 80% of the cholecystectomies are performed laparoscopically (key-hole) (Ballal 2009). The reported proportion of patients with common bile duct stones at the time of cholecystectomy varies between 5% (Kama 2001; Hemli 2004) and 11% (Pitluk 1979; Duensing 2000). Laparoscopic cholecystectomy is currently preferred over open cholecystectomy for elective cholecystectomy (Livingston 2004; Ballal 2009). If stones are found in the common bile duct prior to laparoscopic cholecystectomy, the options include pre-operative or intra-operative endoscopic sphincterotomy (Gurusamy 2011) or laparoscopic common bile duct exploration. If stones are found in the common bile duct for the first time during the laparoscopic cholecystectomy (because of the per-operative cholangiogram), the options include laparoscopic cholecystectomy followed by endoscopic sphincterotomy (Ng 1999), conversion to open procedure (Sarli 2003), or laparoscopic common bile duct exploration (Hyser 1999; Rojas-Ortega 2003; Waage 2003; Ebner 2004). Laparoscopic common bile duct exploration can be either transcystic (Thompson 2002; Rojas-Ortega 2003; Waage 2003) or performed through a choledochotomy (Thompson 2002; Waage 2003) depending upon the size and location of the stones (Jacobs 1991; Memon 2000). Some surgeons use T-tube drainage routinely after choledochotomy and not after successful transcystic common bile duct exploration (Thompson 2002; Rojas-Ortega 2003). Laparoscopic common bile duct exploration can be performed successfully in the majority of the patients (Snow 1999; Thompson 2002; Rojas-Ortega 2003; Hemli 2004).

After the common bile duct exploration is performed, the choice lies between T-tube drainage, primary duct closure with no drainage (Decker 2003), or primary duct closure with biliary stent insertion (Isla 2004; Kim 2004; Griniatsos 2005). T-tube drainage of the common bile duct is performed for the following reasons (Williams 1994):

  • Prevent extravasation of bile from the common bile duct.

  • Post-operative visualization of common bile duct.

  • Availability of T-tube tract extraction of common bile duct with a Burhenne steerable catheter (Burhenne 1973).

T-tube drainage may lead to biliary infection resulting in increased mortality and morbidity in open common bile duct stone exploration (Lygidakis 1983; Wills 2002). Migration of the tube causing common bile duct obstruction (Bernstein 1994) and bile leaks following removal of T-tube have also been reported (Kacker 1995).

This is an update of our previous review (Gurusamy 2007) with revisions in the methodology of the review and interpretation of information according to the current Cochrane Handbook (Higgins 2011).

Objectives

To assess the benefits and harms of T-tube drainage versus primary closure after laparoscopic common bile duct stone exploration.

Methods

Criteria for considering studies for this review

Types of studies

We included all randomised clinical trials examining the effects of T-tube drainage versus primary closure after laparoscopic common bile duct stone exploration irrespective of language, blinding, or publication status.

Quasi-randomised trials (where the method of allocating participants to a treatment are not strictly random, eg, date of birth, hospital record number, alternation) were not included in this review. However, we did include reports of harmful effects from quasi-randomised trials and observational studies.

Types of participants

Participants who were about to undergo laparoscopic exploration of the common bile duct for possible common bile duct stones.

Types of interventions

Any form of T-tube drainage versus primary duct closure without biliary stent insertion after laparoscopic operative exploration of the common bile duct.

Types of outcome measures

Primary outcomes
  1. Mortality.

    1. Mortality at maximal follow-up, usually assessed by hazard ratios.

    2. Mortality within 30 days (procedure or operative mortality).

  2. Serious morbidity, corresponding to Grade 3 or Grade 4 Clavien-Dindo classification (Dindo 2004; Clavien 2009) or as classified by the authors. The Clavien-Dindo classification approximately corresponds to the definition of serious adverse events by the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice (ICH-GCP) (ICH-GCP 1997).

  3. Quality of life.

Secondary outcomes
  1. Operating time.

  2. Length of hospital stay.

  3. Return to work.

  4. Recurrent or retained common bile duct stones at maximal follow-up.

The summary of findings were reported for all the outcomes reported by at least one trial in a Summary of findings for the main comparison using GRADEpro 3.6 (http://ims.cochrane.org/revman/other-resources/gradepro).

Search methods for identification of studies

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded (Royle 2003) until April 2013. We also searched the International Clinical Trials Registry Platform (ICTRP) by World Health Organization (http://apps.who.int/trialsearch/Default.aspx). This search portal allows the search of ClinicalTrials.gov and ISRCTN trial registers among various other trial registers. We have given the search strategies with the time spans for the searches in Appendix 1. References of the identified studies were also searched for further trials.

Data collection and analysis

KSG and RK, independently of each other, identified the trials for inclusion. KSG and RK have also listed the excluded studies with the reasons for the exclusion. BRD adjudicated any differences in opinion.

Both authors independently extracted the following data.

  1. Year and language of publication.

  2. Country.

  3. Year of conduct of the trial.

  4. Inclusion and exclusion criteria.

  5. Sample size.

  6. Population characteristics such as age and sex ratio.

  7. Antibiotic prophylaxis.

  8. Abdominal drain use.

  9. Duration of T-tube drainage.

  10. Whether routine cholangiogram was performed.

  11. Outcomes (mentioned above).

  12. Risk of bias (described below).

We sought any unclear or missing information by contacting the authors of the individual trials. If there was any doubt whether the trials shared the same participants - completely or partially (by identifying common authors and centres), we planned to contact the authors of the trials to clarify whether the trial report had been duplicated.

We resolved any differences in opinion through discussion. BRD adjudicated any differences in opinion.

Assessment of risk of bias

The authors assessed the risk of bias in the trials independently, without masking of the trial names, and following the instructions in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and the Cochrane Hepato-Biliary Group Module (Gluud 2013). Due to the risk of overestimation of intervention effects in randomised trials with high risk of bias (Schulz 1995; Moher 1998; Kjaergard 2001; Wood 2008; Lundh 2012; Savovic 2012), we assessed the influence of risk of bias on the trial results using the following domains.

Allocation sequence generation
  • Low risk of bias: sequence generation was achieved using computer random number generation or a random number table. Drawing lots, tossing a coin, shuffling cards, and throwing dice are adequate if performed by an independent adjudicator.

  • Uncertain risk of bias: the trial was described as randomised, but the method of sequence generation was not specified.

  • High risk of bias: the sequence generation method was not, or might not be, random. Quasi-randomised studies, those using dates, names, or admittance numbers in order to allocate patients were inadequate and were excluded for the assessment of benefits but not for assessing harms.

Allocation concealment
  • Low risk of bias: allocation was controlled by a central and independent randomisation unit, sequentially numbered, opaque and sealed envelopes or similar, so that intervention allocations could not have been foreseen in advance of, or during, enrolment.

  • Uncertain risk of bias: the trial was described as randomised, but the method used to conceal the allocation was not described so that intervention allocations might have been foreseen in advance of, or during, enrolment.

  • High risk of bias: if the allocation sequence was known to the investigators who assigned participants, or if the study was quasi-randomised. Quasi-randomised studies were excluded for the assessment of benefits but not for assessing harms.

Blinding of participants and personnel
  • Low risk of bias: blinding was performed adequately, or the outcome measurement was not likely to be influenced by lack of blinding.

  • Uncertain risk of bias: there was insufficient information to assess whether the type of blinding used was likely to induce bias on the estimate of effect.

  • High risk of bias: no blinding or incomplete blinding, and the outcome or the outcome measurement was likely to be influenced by lack of blinding.

Blinding of outcome assessors
  • Low risk of bias: blinding was performed adequately, or the outcome measurement was not likely to be influenced by lack of blinding.

  • Uncertain risk of bias: there was insufficient information to assess whether the type of blinding used was likely to induce bias on the estimate of effect.

  • High risk of bias: no blinding or incomplete blinding, and the outcome or the outcome measurement was likely to be influenced by lack of blinding.

Incomplete outcome data
  • Low risk of bias: the underlying reasons for missing data were unlikely to make treatment effects depart from plausible values, or proper methods had been employed to handle missing data.

  • Uncertain risk of bias: there was insufficient information to assess whether the missing data mechanism in combination with the method used to handle missing data were likely to induce bias on the estimate of effect.

  • High risk of bias: the crude estimate of effects (eg, complete case estimate) were clearly biased due to the underlying reasons for missing data, and the methods used to handle missing data were unsatisfactory.

Selective outcome reporting
  • Low risk of bias: pre-defined, or clinically relevant and reasonably expected outcomes were reported on.

  • Uncertain risk of bias: not all pre-defined or clinically relevant and reasonably expected outcomes were reported on, or were not reported fully, or it was unclear whether data on these outcomes were recorded or not.

  • High risk of bias: one or more clinically relevant and reasonably expected outcomes were not reported on; data on these outcomes were likely to have been recorded.

Vested interest bias
  • Low risk of bias: the trial was conducted by a party without any vested interest in the outcome of the trial.

  • Uncertain risk of bias: it was not clear if the trial was conducted by a party with a vested interest in the outcome of the trial.

  • High risk of bias: the trial was conducted by a party with one or more vested interests in the outcome of the trial (such as a T-tube manufacturer).

We considered trials to be of low risk of bias if we assessed all the above domains being of low risk of bias. In all other cases, the trials were considered having high risk of bias.

Statistical methods

We performed the meta-analyses according to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and the Cochrane Hepato-Biliary Group Module (Gluud 2013). We used the software package Review Manager 5 for all statistical analyses (RevMan 2012). For dichotomous variables, we calculated the risk ratio (RR) with 95% confidence intervals (CI) if there were two or more trials for an outcome. For continuous outcomes we calculated the mean difference (MD) and the standardised mean difference (SMD) if different assessment scales were used with 95% confidence intervals. For serious morbidity, we calculated the proportion of patients with serious morbidity and the number of serious morbidities ('serious morbidity rate') in each group. While the proportion of patients with serious morbidity is a binary outcome, the serious morbidity rate is a count data outcome. For count data outcomes such as serious adverse events, the rate ratio was calculated using the methods shown in section 9.4.8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). For such a calculation, one needs the time that the patients were exposed to the risk of serious morbidity in each of the groups. We considered that both groups were exposed to the risk of serious morbidity for the same time period, which is a reasonable assumption considering that the patients were followed up for the same time in both groups.

We used a random-effects model (DerSimonian 1986) and a fixed-effect model (DeMets 1987) for meta-analysis in the presence of two or more trials included under the outcomes. In case of discrepancy between the two models, we have reported both results; otherwise we have reported the results of the fixed-effect model. Heterogeneity was explored by a chi-squared test with significance set at P value 0.10, and the quantity of heterogeneity was measured by I2 (Higgins 2002; Higgins 2011).

The analyses were performed on an intention-to-treat basis (Newell 1992) whenever possible. Otherwise, we adopted the 'available-patient analysis' (Higgins 2011). We did not impute any data for the post-randomisation drop-outs for any of the continuous outcomes. In the absence of summary information such as mean and standard deviation for continuous outcomes, we used the median for the meta-analysis when the mean was not available and imputed the standard deviation from P values according to the instructions given in the Cochrane Handbook for Systematic Reviews of Intervention (Higgins 2011) (See Sensitivity analysis below). If it was not possible to calculate the standard deviation from the P value or the confidence intervals, we imputed the standard deviation as the highest standard deviation in the other trials included under that outcome, fully recognising that this form of imputation would decrease the weight of the study for calculation of mean differences and bias the effect estimate to no effect in case of standardised mean difference (Higgins 2011).

Reporting bias

We planned to use a funnel plot to explore reporting bias (Egger 1997; Macaskill 2001) in the presence of at least 10 trials. We planned to use asymmetry in funnel plot of study size against treatment effect to identify bias. We also planned to perform linear regression approach described by Egger (Egger 1997) to determine the funnel plot asymmetry.

Subgroup analysis

We planned to perform the following subgroup analyses:

  • Trials at low risk of bias compared to those at high risk of bias.

  • Trials in which routine antibiotic prophylaxis was used compared to those in which routine antibiotic prophylaxis was not used.

  • Trials in which patients underwent laparoscopic common bile duct exploration in the presence of acute cholecystitis compared to those in which patients underwent laparoscopic common bile duct exploration in the absence of acute cholecystitis.

We planned to use the test for subgroup differences available through RevMan.

Sensitivity analysis

We planned to perform a sensitivity analysis by imputing the outcomes for binary outcomes under different scenarios, namely best-best analysis, worst-worst analysis, best-worst analysis, and worst-best analysis (Gurusamy 2009; Gluud 2013) for any significant binary outcomes. We performed a sensitivity analysis by excluding the trials in which median or standard deviation was imputed for continuous outcomes. Both these sensitivity analyses were planned a priori (Gurusamy 2007). We also performed post-hoc sensitivity analyses by considering the complications for which the severity could not be determined as 'mild' complications (best-best scenario) and then we considered these 'mild' complications as severe complications (worst-worst scenario). For example, bile leaks are post-operative complications some of which resolve spontaneously without any prolongation of hospital stay and hence were categorised as 'mild' adverse events. Other bile leaks need radiological or endoscopic interventions and hence were classified as 'serious' adverse events. If the trial authors did not report the way the bile leaks were treated, it was not possible to determine their severity. So, we performed two analyses - one, excluding the bile leaks which resolved spontaneously and those, for which the treatment was not reported, and another analysis including the bile leaks for which the treatment was not reported.

Trial sequential analysis

Trial sequential analysis was applied because cumulative meta-analyses are at risk of producing random errors due to sparse data and repetitive testing of the accumulating data (CTU 2011; Thorlund 2011). To minimise random errors, we calculated the required information size (ie, the number of participants needed in a meta-analysis to detect or reject a certain intervention effect). The required information size calculation should also account for the heterogeneity or diversity present in the meta-analysis. The underlying assumption of trial sequential analysis is that testing for significance may be performed each time a new trial is added to the meta-analysis. We added the trials according to the year of publication, and if more than one trial was published in a year, the trials were added alphabetically according to the last name of the first author. On the basis of the required information size, trial sequential monitoring boundaries were constructed. These boundaries determine the statistical inference one may draw regarding the cumulative meta-analysis that has not reached the required information size; if the trial sequential monitoring boundary is crossed before the required information size is reached, firm evidence may perhaps be established and further trials may turn out to be superfluous. On the other hand, if the boundary is not surpassed, it is most probably necessary to continue doing trials in order to detect or reject a certain intervention effect.   

We performed trial sequential analysis for binary outcomes and continuous outcomes in which at least two trials were present to determine if further trials are necessary on the topic (CTU 2011; Thorlund 2011). We performed the trial sequential analysis using an alpha error of 5%, beta error of 20%, control event proportion obtained from the results, and a relative risk reduction of 20% for binary outcomes (Brok 2008; Wetterslev 2008; Brok 2009; Thorlund 2009; Wetterslev 2009; Thorlund 2010). For continuous outcomes, we conducted the trial sequential analysis using alpha error of 5%, beta error of 20%, the variance of the included trials, and a minimal clinically important difference of one day for hospital stay and 15 minutes for operating time.

Results

Description of studies

We identified a total of 1752 references through electronic searches of Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (n = 179), MEDLINE (n = 759), EMBASE (n = 369), and Science Citation Index Expanded (n = 445). We excluded 542 duplicates and 1203 clearly irrelevant references through reading abstracts. Seven references were retrieved for further assessment. No trials were identified from the ICTRP portal or through scanning reference lists of the identified randomised trials. Of the seven references, we excluded three because of the reasons listed in the table 'Characteristics of excluded studies'. In total, four references of three randomised trials fulfilled the inclusion criteria (Leida 2008; Zhang 2009; El-Geidie 2010). The reference flow is shown in Figure 1. Details of the trials are shown in the table 'Characteristics of included studies'.

Figure 1.

Study flow diagram.

Included trials

A total of 295 participants who underwent laparoscopic common bile duct exploration were randomised in three trials (Leida 2008; Zhang 2009; El-Geidie 2010). The number of participants in each trial ranged from 80 to 122. The average age in all the three trials was about 50 years. The proportion of females in the trials was about 60% (Characteristics of included studies).

Antibiotic use was not reported in any of the trials. Intra-abdominal drains were used in all three trials. The timing of removal of the T-tube and whether a T-tube cholangiogram was performed are described in the Characteristics of included studies table.

Risk of bias in included studies

All the trials were assessed as having high risk of bias (Figure 2; Figure 3).

Figure 2.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 3.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Effects of interventions

See: Summary of findings for the main comparison T-tube drainage compared to primary closure after laparoscopic common bile duct exploration

The results are summarised in Summary of findings for the main comparison.

Mortality

Mortality at maximal follow-up

None of the trials reported long-term outcomes.

Mortality within 30 days (procedure or operative mortality)

All three trials reported this outcome. There was no peri-operative mortality in either group (Analysis 1.1).

Serious morbidity (serious complications)

All three trials provided results on serious complications, although the severity of the complications was not available for two participants in the T-tube group in one of the trials (Zhang 2009). We performed an analysis considering that the morbidity in these two patients were not severe (best-best scenario) (Analysis 1.2; Analysis 1.4) and another analysis considering that the morbidity in these patients were severe (worst-worst scenario) (Analysis 1.3; Analysis 1.5). In the best-best scenario, there was no significant difference in the serious morbidity rates (rate ratio 1.59; 95% CI 0.66 to 3.83; P = 0.30; I2 = 50%) (Analysis 1.2) or in the proportion of patients who developed serious morbidity (RR 1.86; 95% CI 0.87 to 3.96; P = 0.11; I2 = 55%) (Analysis 1.4). The results were not altered sufficiently to change the interpretation by performing the worst-worst scenario (Analysis 1.3; Analysis 1.5).

Trial sequential analysis

The information fraction was only 1.03%, and so, the trial sequential monitoring boundaries and the required information size (n = 28,572 patients) were not drawn (Figure 4).

Figure 4.

Trial sequential analysis of serious morbidity
The diversity-adjusted required information size (DARIS) was calculated to 28,572 patients, based on the proportion of patients in the control group with the outcome of 6.1%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 61.69%. After accruing 295 patients in the three trials, we have only reached 1.03% of the DARIS. Accordingly, the trial sequential analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional boundaries have also not been crossed.

Quality of life

None of the included trials reported on quality of life.

Operating time

All three trials reported this outcome. The mean value of the operating time was missing in one trial and was imputed from the median (Leida 2008).The standard deviation was not reported in two trials (Leida 2008; El-Geidie 2010). The standard deviation was calculated using the P value in one trial (El-Geidie 2010) and from the inter-quartile range in another trial (Leida 2008). The meta-analysis showed that the operating time was significantly longer in the T-tube group than in the primary closure group (MD 21.22 minutes; 95% CI 12.44 to 30.00; P < 0.00001; I2 = 0%) (Analysis 1.6). The results were not changed by excluding the trials in which means or standard deviations were imputed.

Trial sequential analysis

The trial sequential analysis of operating time shows that the accumulative Z-curve crosses the trial sequential monitoring boundary after the second trial favouring primary closure. The diversity-adjusted required information size (DARIS) was 414 patients based on a minimal relevant difference (MIRD) of 15 minutes, a variance (VAR) of 2962, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 0%. The results are compatible with significant reduction of operation time favouring the primary closure group without risk of random errors (Figure 5).

Figure 5.

Trial sequential analysis of operating time
This figure shows that the accumulative Z-curve crosses the trial sequential monitoring boundary during the second trial (see the dashed line). The diversity-adjusted required information size (DARIS) was 414 patients based on a minimal relevant difference (MIRD) of 15 minutes, a variance (VAR) of 2962, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 0%. The results are compatible with significant reduction of operation time favouring the primary closure group without risk of random errors.

Hospital stay

All three trials reported this outcome. As in the case of operating time, the standard deviation was imputed from P value in one trial (El-Geidie 2010) and from the inter-quartile range in another trial (Leida 2008). The mean was imputed from the median in one trial (Leida 2008). The hospital stay was significantly longer in the T-tube group than in the primary closure group (MD 3.26 days; 95% CI 2.49 to 4.04; P < 0.00001; I2 = 0%) (Analysis 1.7). The results did not change by excluding the trials in which mean or standard deviation were imputed.

Trial sequential analysis

The trial sequential analysis of hospital stay shows that the accumulative Z-curve does not cross the trial sequential monitoring boundary after the second trial. The diversity-adjusted required information size (DARIS) was 724 patients based on a minimal relevant difference (MIRD) of one day, a variance (VAR) of 23.04, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 0%. The results are compatible with significant reduction of hospital stay favouring the primary closure group without risk of random errors (Figure 6).

Figure 6.

Trial sequential analysis of duration of hospital stay
This figure shows that the accumulative Z-curve crosses the trial sequential monitoring boundary during the second trial. The diversity-adjusted required information size (DARIS) was 724 patients based on a minimal relevant difference (MIRD) of one day, a variance (VAR) of 23.04, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 0%. The results are compatible with significant reduction of hospital stay favouring the primary closure group without risk of random errors.

Return to work

This outcome was reported in only one trial (Leida 2008). This trial reported only the median of number of days before returning to work and inter-quartile range. The participants in the T-tube group returned to work about eight days later than the participants in the primary closure group (P < 0.005) (Analysis 1.8).

Recurrent or retained common bile duct stones at long-term follow-up

None of the trials reported this outcome.

Subgroup analysis

All the trials were of high risk of bias. None of the trials reported whether antibiotics were used and the trials did not report the outcomes for participants with acute cholecystitis separately. So the subgroup analyses were not performed.

Reporting bias

We did not perform a funnel plot because only three trials were included in this review.

Discussion

Summary of main results

This systematic review shows that T-tube drainage might increase the operating time and hospital stay without any evidence of difference in serious complications. One of the reasons for considering the employment of T-tube drainage is to decompress the common bile duct if there is distal obstruction (Williams 1994). This is to avoid bile leak and bile peritonitis. In the three trials including 148 patients allocated to the primary closure group (Leida 2008; Zhang 2009; El-Geidie 2010), the biliary complications in the primary closure group included one patient with bile leak requiring endoscopic stent (Zhang 2009), one patient with bile leak requiring percutaneous drainage (Leida 2008), and another patient developing biliary pancreatitis requiring endoscopic stent (Leida 2008). In contrast, of the 147 patients belonging to the T-tube closure group in the three trials (Leida 2008; Zhang 2009; El-Geidie 2010), the biliary complications included seven patients who required open re-operations for bile peritonitis, T-tube dislodgement, or bleeding from the choledochotomy wound, three patients requiring percutaneous drainage for bile leak, and one patient developing acute pancreatitis which settled without any surgical, endoscopic, or radiological intervention (Leida 2008; Zhang 2009; El-Geidie 2010). Thus, there is no evidence that the T-tube is preventing bile leaks. There is also no evidence that the proportion of patients with serious morbidity or serious morbidity rates were different between the two groups. Long-term follow-up is necessary to detect any bile strictures and recurrence of common bile duct stones. There is no current evidence to suggest that these will be different between the groups.

Another reason for considering T-tube drainage is to extract any residual stones through the T-tube tract (Williams 1994). Even if patients develop symptomatic retained stones, endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy can be used for the treatment. Before the advent of endoscopic sphincterotomy, percutaneous transhepatic biliary drainage or open exploration were the only options available for the treatment of such patients. Although T-tube drainage to facilitate extraction of stones may have been appropriate in the past, this has become redundant with the currently available treatments.

The operating time was significantly longer in the T-tube group than in the primary closure group. This is expected because the T-tube involves additional steps during surgery.

The post-operative hospital stay was significantly longer in the T-tube group than for the primary closure group. The patients were discharged home with the T-tube in situ in all three trials included in this review (Leida 2008; Zhang 2009; El-Geidie 2010). So, the differences in the post-operative hospital stay cannot be explained by a delayed discharge for T-tube cholangiogram. While there was no significant difference in the serious morbidity rates between the two groups, this may be due to lack of evidence of effect rather than lack of effect. In the absence of any other explanation for the prolonged post-operative hospital stay, one has to conclude that the longer hospital stay in the T-tube group than primary closure group is due to higher morbidity.

The time taken to return to work was significantly longer in the T-tube group than for the primary closure group. This may be related to the presence of the T-tube itself which may discourage the patient to return to work or may be related to associated morbidity. As mentioned previously, lack of evidence of significant differences in serious morbidity should not be considered as evidence for lack of effect. The confidence intervals were wide and there is a possibility that this finding of lack of significant differences in serious morbidity rates could be because of lack of evidence of effect. Quality of life, another patient-oriented outcome, was not reported in any of the trials included in this review.

A longer post-operative hospital stay is neither beneficial to the patient (particularly in a private healthcare funding set-up) nor to the healthcare provider (particularly in a state-funded or insurance company funded healthcare funding set-up). In addition to the shorter hospital stay, the other cost-savings that can be made in the primary closure include the cost of the T-tube, increased operating time, the cost of T-tube cholangiogram, and the cost of removal of the T-tube. Unless these costs can be offset by decreased complications, the costs associated with the use of a T-tube cannot be justified. Based on the evidence from this review, this does not appear to be the case. Consequently, there appears to be little justification in the use of a T-tube after laparoscopic common bile duct exploration.

It appears that T-tube use has a significant potential to harm the patients and increase the costs for the healthcare funder without any notable benefit based on the information obtained from the trials included in this review. There is additional corroborative information. We identified three non-randomised studies comparing T-tube with primary closure (Ha 2004; Jameel 2008; Noh 2009) from the search strategy. None of the studies reported any biliary peritonitis (T-tube drainage: 0/26 (0%) (Ha 2004); 0/11 (0%) (Jameel 2008); 0/33 (0%) (Noh 2009) versus primary closure: 0/12 (0%) (Ha 2004); 0/48 (0%) (Jameel 2008); 0/30 (0%) (Noh 2009)). In addition, in another Cochrane review, which included 359 patients from six trials, we found that T-tube closure had longer operating time and hospital stay than primary closure of the common bile duct without stent after open common bile duct exploration, without affecting the serious morbidity rates significantly (Gurusamy 2013). In that Cochrane review of T-tube drainage versus primary closure in patients undergoing open common bile duct exploration, fewer patients developed biliary complications requiring intervention (not statistically significant) (Gurusamy 2013) as is the case with this review. The purpose of T-tube drainage is the same whether the patients undergo open or laparoscopic common bile duct exploration. Thus, there is a strong corroborative evidence that supports the findings of this review.

Overall completeness and applicability of evidence

This review is applicable in only patients undergoing laparoscopic common bile duct exploration for common bile duct stones and without distal obstruction to the flow of bile.

Quality of the evidence

Although the risk of bias in the included trials was high and the overall quality of evidence was very low, one has to put this into perspective. This is currently the best available evidence. The previous routine use of T-tube was based on clinical opinion and the fact that a significant proportion of the patients had to undergo major re-operations where stones were left in the bile duct. The advent of endoscopic sphincterotomy appears to have made the use of the T-tube redundant. The trials were at high risk of bias (for example, outcomes such as hospital stay and return to work can be biased because of lack of blinding and absence of any criteria for discharge from hospital or return to work, and a surgeon favouring primary closure might have discharged the patient from hospital earlier or might have advised the patient that he or she could return to work earlier) and new trials are necessary to assess whether T-tube drainage is better than primary closure after laparoscopic common bile duct exploration, as shown by the trial sequential analysis. Until such new trials with low risk of bias show that T-tube use is safe and effective, the use of T-tube after laparoscopic common bile duct exploration should be confined to randomised clinical trials. Such randomised trials should include quality of life and return to work as these outcomes are useful to determine whether T-tube is beneficial to the patient and whether it is cost-effective.

Potential biases in the review process

We have followed the Cochrane methodology for performing the review. One potential bias was that we imputed the mean and standard deviation from median and other measures such as P values or inter-quartile ranges. This may have introduced an error in the effect estimate. The sensitivity analysis by excluding the trials in which the imputation was performed did not change the results. The alternative to this imputation is to present the information as presented by the authors, but the interpretation of that information can be even more confusing.

Agreements and disagreements with other studies or reviews

In the previous version of this review, we stated that we could not make any conclusions because of the data available at that time (Gurusamy 2007). In this review, we advocate against the use of T-tube outside well-designed randomised clinical trials.

Authors' conclusions

Implications for practice

T-tube drainage appears to result in significantly longer operating time and hospital stay as compared to primary closure, without any evidence of benefit after laparoscopic common bile duct exploration. Based on currently available evidence, there is no justification for the routine use of T-tube drainage after laparoscopic common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well-designed randomised clinical trials.

Implications for research

Further adequately powered trials of low risk of bias are necessary. Such trials ought to report in detail on mortality, adverse events, quality of life, and return to work as well as outcomes addressed in this systematic review. Furthermore, such trials should be designed according to the SPIRIT guidelines (Chan 2013) and reported according to the CONSORT guidelines (http://www.consort-statement.org).

Acknowledgements

To The Cochrane Hepato-Biliary Group who provided support and guidance.
To K Samraj who independently identified the trials and extracted the data for the first version of the review.

Peer reviewer for the first version of the review: PW Jorgensen, for suggesting improvements to the first version of the review.
Z Yu (China), who contributed to the background section of the protocol, which has been revised significantly.
M Wei, the Chinese Cochrane Centre, who helped with the translation of a Chinese paper for the first version of the review.

Peer reviewers: Kyeon Kook Lee, South Korea; Ahmed Abdel-Raouf El-Geidie, Egypt; Janus Jakobsen, Denmark.
Contact editors: Christian Gluud, Denmark; Ronald Koretz, USA.

This project was funded by the National Institute for Health Research (NIHR).

Disclaimer

Department of Health disclaimer: the views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS (National Health Service), or the UK Department of Health.

Data and analyses

Download statistical data

Comparison 1. T-tube drainage versus primary closure
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Mortality  Other dataNo numeric data
2 Serious morbidity (best-best scenario)3295Rate Ratio (Fixed, 95% CI)1.59 [0.66, 3.83]
3 Serious morbidity (worst-worst scenario)3295Rate Ratio (Fixed, 95% CI)1.80 [0.78, 4.11]
4 Serious morbidity (best-best scenario)3295Risk Ratio (M-H, Fixed, 95% CI)1.86 [0.87, 3.96]
5 Serious morbidity (worst-worst scenario)3295Risk Ratio (M-H, Fixed, 95% CI)2.07 [0.99, 4.34]
6 Operating time3295Mean Difference (IV, Fixed, 95% CI)21.22 [12.44, 30.00]
7 Hospital stay3295Mean Difference (IV, Fixed, 95% CI)3.26 [2.49, 4.04]
8 Return to work  Other dataNo numeric data

Analysis 1.1.

Comparison 1 T-tube drainage versus primary closure, Outcome 1 Mortality.

Mortality
StudyT-tube drainagePrimary closureFisher's exact test P value
El-Geidie 20100/610/611
Leida 20080/400/401
Zhang 20090/460/471
Analysis 1.2.

Comparison 1 T-tube drainage versus primary closure, Outcome 2 Serious morbidity (best-best scenario).

Analysis 1.3.

Comparison 1 T-tube drainage versus primary closure, Outcome 3 Serious morbidity (worst-worst scenario).

Analysis 1.4.

Comparison 1 T-tube drainage versus primary closure, Outcome 4 Serious morbidity (best-best scenario).

Analysis 1.5.

Comparison 1 T-tube drainage versus primary closure, Outcome 5 Serious morbidity (worst-worst scenario).

Analysis 1.6.

Comparison 1 T-tube drainage versus primary closure, Outcome 6 Operating time.

Analysis 1.7.

Comparison 1 T-tube drainage versus primary closure, Outcome 7 Hospital stay.

Analysis 1.8.

Comparison 1 T-tube drainage versus primary closure, Outcome 8 Return to work.

Return to work
StudyT-tube: median (inter-quartile range) days (number of patients = 40)Primary closure: median (inter-quartile range) days (number of patients = 40)Mean difference (95% confidence intervals)P value
Leida 200820.4 (13.2)12.6 (5.1)7.8 days (1.88 to 13.72)0.005

Appendices

Appendix 1. Search strategies for identification of studies

DatabaseTimespanSearch strategy
Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Wiley)Issue 3, 2013#1 MeSH descriptor Cholelithiasis explode all trees in MeSH products
#2 MeSH descriptor Gallstones explode all trees in MeSH products
#3 MeSH descriptor Common Bile Duct explode all trees in MeSH products
#4 MeSH descriptor Cholestasis explode all trees in MeSH products
#5 MeSH descriptor Jaundice, Obstructive explode all trees in MeSH products
#6 gall stone* or gallstone* or cholelithiasis or common bile duct* or cholecystolithiasis or cholestasis or choledocholithiasis or obstructive jaundice in All Fields in all products
#7 (#1 OR #2 OR #3 OR #4 OR #5 OR #6)
#8 MeSH descriptor Drainage explode all trees in MeSH products
#9 MeSH descriptor Decompression, Surgical explode all trees in MeSH products
#10 drain* or decompression in All Fields in all products
#11 (#8 OR #9 OR #10)
#12 (#7 AND #11)
MEDLINE (PubMed)1946 to April 2013 ("Cholelithiasis"[MeSH] OR "Gallstones"[MeSH] OR "Common Bile Duct"[MeSH] OR "Cholestasis"[MeSH] OR "Jaundice, Obstructive"[MeSH] OR gall*stone* or cholelithiasis or common bile duct* or cholecystolithiasis or cholestasis or choledocholithiasis or obstructive jaundice) AND (drain* or decompression OR "Drainage"[MeSH] OR "Decompression, Surgical"[MeSH]) AND ((randomised controlled trial [pt] OR controlled clinical trial [pt] OR randomised [tiab] OR placebo [tiab] OR drug therapy [sh] OR randomly [tiab] OR trial [tiab] OR groups [tiab]) NOT (animals [mh] NOT humans [mh]))
EMBASE (OvidSP)1947 to April 2013

1. exp cholelithiasis/ or exp cholestasis/ or exp obstructive jaundice/

2. (gallstone* or gall stone* or gall-stone* or cholelithiasis or common bile duct* or cholecystolithiasis or cholestasis or choledocholithiasis or obstructive jaundice).af.

3. 1 or 2

4. exp drain/

5. (drain* or decompression).af.

6. 4 or 5

7. 3 and 6

8. exp crossover-procedure/ or exp double-blind procedure/ or exp randomised controlled trial/ or single-blind procedure/

9. (random* or factorial* or crossover* or placebo*).af.

10. 8 or 9

11. 7 and 10

Science Citation Index Expanded (SCI Expanded)
(ISI Web of Knowledge)
1898 to April 2013#1 TS=(gall stone* or gallstone* or cholelithiasis or common bile duct* or cholecystolithiasis or cholestasis or choledocholithiasis or obstructive jaundice)
#2 TS=drain* or decompression
#3 #1 and #2
#4 TS=(random* OR blind* OR placebo* OR meta-analysis)
#5 #3 and #4
International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/Default.aspx)April 2013common bile duct or choledocholithiasis

What's new

DateEventDescription
16 April 2013AmendedThe title has been revised since the T-tube drainage intervention has additional steps compared to primary closure.
10 April 2013New search has been performedThe search was updated, but no additional trials were found.
17 February 2012New search has been performed

The search was updated, and two new trials meeting the inclusion criteria were included.

Trial sequential analysis was performed.

17 February 2012New citation required and conclusions have changed

The methods were updated according to version 5.1 of the Cochrane Handbook (Higgins 2011). This involved changes of the outcomes so that they are now of relevance also to the patients and changes to the risk of bias domains. This resulted in a change in the findings and conclusions of the review.

The intervention 'primary closure with biliary stent' was considered to be very different from 'primary closure without biliary stent'. Hence the intervention 'primary closure with biliary stent' was excluded from the review. 'Primary closure with a biliary stent' should be the subject of another review.

Contributions of authors

K Gurusamy identified trials, extracted data, analysed the data, and interpreted the data. R Koti independently identified trials and extracted data for the current version of the review. BR Davidson critically commented on the review.

Declarations of interest

None known.

Sources of support

Internal sources

  • University College London, UK.

External sources

  • National Institute of Health Research, UK.

Differences between protocol and review

The protocol for the present review was published with the title 'T-tube drain in laparoscopic common bile duct stone exploration' (Gurusamy 2006). During the review preparation we felt that we would achieve greater clarity if we changed the review title into 'T-tube drainage versus primary closure after laparoscopic common bile duct exploration'.

Differences between previous version and current version

  • T-tube drainage was changed to intervention, and primary closure was changed to control. This is because T-tube drainage contains additional steps in surgery as compared to primary closure.

  • The methods were updated according to version 5.1 of the Cochrane Handbook (Higgins 2011). This involved changes of the outcomes and the risk of bias domains. This resulted in changes in the findings and conclusions of the review.

  • The intervention 'primary closure with biliary stent' was considered to be very different from 'primary closure without biliary stent'. Hence, the intervention 'primary closure with biliary stent' was excluded from the review. 'Primary closure with a biliary stent' should be considered in another review.

  • Trial sequential analysis was performed.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

El-Geidie 2010

MethodsRandomised clinical trial
ParticipantsCountry: Egypt.
Number randomised: 122.
Post-randomisation drop-outs: 0 (0%).
Revised sample size: 122.
Average age: 49 years.
Females: 84 (68.9%).
Inclusion criteria
1. Patients undergoing laparoscopic choledochotomy.
2. Fluoroscopic confirmation of CBD duct clearance.
Exclusion criteria
1. Patients undergoing transcystic duct exploration.
2. Patients requiring laparoscopic choledochoduodenostomy.
3. Patients with pancreatitis.
4. Cholangitis.
5. Post-cholecystectomy patients.
6. Patients with contra-indication to laparoscopy.
Interventions

Participants were randomly assigned to two groups.
Group 1: T-tube (n = 61).

Group 2: primary closure (n = 61).
1. Biliary stent: no.
2. Antibiotics: not mentioned.
3. Abdominal drains: yes.
4. T-tube cholangiogram: 10th day.
5. T-tube removal: once the T-tube cholangiogram confirmed that the CBD was clear.

OutcomesThe outcomes reported were mortality, morbidity, operating time, and hospital stay.
NotesAttempts were made to contact the authors in February 2012.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskComment: This information was not available.
Allocation concealment (selection bias)Unclear risk

Quote: Patients were randomly assigned to either primary closure or T-tube drainage by means of the closed envelope method.

Comment: Further details were not available.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: This information was not available.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: This information was not available.
Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: There were no post-randomisation drop-outs.
Selective reporting (reporting bias)Low riskComment: Mortality and morbidity were reported.
Vested interest biasUnclear riskComment: This information was not available.

Leida 2008

MethodsRandomised clinical trial
ParticipantsCountry: China.
Number randomised: 80.
Post-randomisation drop-outs: 0 (0%).
Revised sample size: 80.
Average age: 49 years.
Females: 45 (56.3%).
Inclusion criteria
1. Patients undergoing laparoscopic choledochotomy.
2. Age > 12 years.
Exclusion criteria
1. Patients withe suppurative cholangitis.
2. Severe acute biliary pancreatitis.
3. Ampullary stenosis.
4. Previous gastrectomy.
5. Failed ERCP.
Interventions

Participants were randomly assigned to two groups.
Group 1: T-tube (n = 40).

Group 2: primary closure (n = 40).
1. Biliary stent: no.
2. Antibiotics: not mentioned.
3. Abdominal drains: yes.
4. T-tube cholangiogram: 7th day.
5. T-tube removal: 3 to 4 weeks from operation.

OutcomesThe outcomes reported were mortality, morbidity, operating time, hospital stay, and return to work.
NotesAttempts were made to contact the authors in February 2012.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: Randomization was performed with the use of a computer-generated randomisation schedule with blocks of four randomly assigned numbers. 
Allocation concealment (selection bias)Unclear riskComment: This information was not available.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: This information was not available.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: This information was not available.
Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: There were no post-randomisation drop-outs.
Selective reporting (reporting bias)Low riskComment: Mortality and morbidity were reported.
Vested interest biasUnclear riskComment: This information was not available.

Zhang 2009

  1. a

    CBD = common bile duct.
    ERCP = endoscopic retrograde cholangiopancreatography.
    Fr. = French gauge.

MethodsRandomised clinical trial
ParticipantsCountry: China.
Number randomised: 93.
Post-randomisation drop-outs: 0 (0%).
Revised sample size: 93.
Average age: 52 years.
Females: 52 (55.9%).
Inclusion criteria
1. Patients undergoing laparoscopic choledochotomy.
2. Age > 18 years.
Exclusion criteria
1. History of previous upper abdominal surgery.
2. Severe acute cholecystitis.
3. Severe gallstone pancreatitis.
4. Acute pyogenic cholangitis.
5. Ampullary stenosis with multiple intrahepatic stones.
6. Suspected biliary tumour.
Interventions

Participants were randomly assigned to two groups.
Group 1: T-tube (n = 46).

Group 2: primary closure (n = 47).
1. Biliary stent: no.
2. Antibiotics: not mentioned.
3. Abdominal drains: yes.
4. T-tube cholangiogram: 3rd to 5th day.
5. T-tube removal: 3 to 5 weeks.

OutcomesThe outcomes reported were mortality, morbidity, operating time, and hospital stay.
NotesAttempts were made to contact the authors in February 2012.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: Patients were randomly assigned to either primary closure or T-tube drainage by means of the Research Randomizer (http://www.randomizer.org/form.htm). Comment: This is a method of computer generated randomisation schedule.
Allocation concealment (selection bias)Unclear riskComment: This information was not available.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: This information was not available.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: This information was not available.
Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: There were no post-randomisation drop-outs.
Selective reporting (reporting bias)High riskComment: The outcomes of some patients were not reported to allow us to assess the severity of the morbidity.
Vested interest biasUnclear riskComment: This information was not available.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Ha 2004Not a randomised clinical trial.
Jameel 2008Not a randomised clinical trial.
Noh 2009Not a randomised clinical trial.

Ancillary