Intervention Review

Cholecystectomy deferral in patients with endoscopic sphincterotomy

  1. Vivian McAlister1,*,
  2. Eric Davenport2,
  3. Elizabeth Renouf3

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 17 OCT 2007

Assessed as up-to-date: 27 JUL 2007

DOI: 10.1002/14651858.CD006233.pub2


How to Cite

McAlister V, Davenport E, Renouf E. Cholecystectomy deferral in patients with endoscopic sphincterotomy. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD006233. DOI: 10.1002/14651858.CD006233.pub2.

Author Information

  1. 1

    Canadian Forces, 1 Canadian Field Hospital, London, Ontario, Canada

  2. 2

    University of Western Ontario, Surgery, Division of General Surgery, London, Ontario, Canada

  3. 3

    London, Canada

*Vivian McAlister, 1 Canadian Field Hospital, Canadian Forces, C4-212, University Hospital, London, Ontario, N6A 5A5, Canada. vmcalist@uwo.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 17 OCT 2007

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Cholecystectomy is not required in up to 64% of patients who adopt a wait-and-see policy after endoscopic clearance of common bile duct stones. Although reports of retrospective cohort series have shown a higher mortality among patients who defer cholecystectomy, it is not known if this is due to the patients' premorbid health status or due to the deferral of cholecystectomy. Randomised clinical trials of prophylactic cholecystectomy versus wait-and-see have not had sufficient power to demonstrate differences in survival.

Objectives

To evaluate the beneficial and harmful effects of cholecystectomy deferral (wait-and-see) versus elective (prophylactic) cholecystectomy in patients who have had an endoscopic biliary sphincterotomy.

Search methods

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Controlled Trials Register (CENTRAL) in The Cochrane Library, MEDLINE (1966 to 2007), EMBASE (1980 to 2007), and Science Citation Index Expanded without language restrictions until April 2007.

Selection criteria

Randomised clinical trials comparing patients whose gallbladder was left in-situ after endoscopic sphincterotomy (wait-and-see group) versus patients who had cholecystectomy with either endoscopic sphincterotomy or common bile duct exploration (prophylactic cholecystectomy group), irrespective of blinding, language, or publication status.

Data collection and analysis

We assessed the impact of a wait-and-see policy on mortality. Secondary outcomes assessed were the incidence of biliary pain, cholangitis, pancreatitis, need for cholangiography, need for cholecystectomy, and the rate of difficult cholecystectomy. We pooled data using relative risk with fixed-effect and random-effects models.

Main results

We included 5 randomised trials with 662 participants out of 93 publications identified through the literature searches. The number of deaths was 47 in the wait-and-see group (334 patients) compared to 26 in the prophylactic cholecystectomy group (328 patients) for a 78% increased risk of mortality (RR 1.78, 95% CI 1.15 to 2.75, P = 0.010). The survival benefit of prophylactic cholecystectomy was independent of trial design, inclusion of high risk patients or inclusion of any one of the five trials. Patients in the wait-and-see group had higher rates of recurrent biliary pain (RR 14.56, 95% CI 4.95 to 42.78, P < 00001), jaundice or cholangitis (RR 2.53, 95% CI 1.09 to 5.87, P = 0.03), and of repeat ERCP or other forms of cholangiography (RR 2.36, 95% CI 1.29 to 4.32, P = 0.005). Cholecystectomy was eventually performed in 35% (115 patients) of the wait-and-see group.

Authors' conclusions

Prophylactic cholecystectomy should be offered to patients whose gallbladders remain in-situ after endoscopic sphincterotomy and common bile duct clearance.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Prophylactic cholecystectomy should be offered to patients whose gallbladders remain in-situ after endoscopic sphincterotomy and common bile duct clearance

Surgical removal of the gallbladder is done routinely. Stones in the common bile duct usually come from the gallbladder and can be harmful. The usual treatment for gallstones that are in the common bile duct is endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy. ERCP is an endoscopic procedure to remove stones from the common bile duct. More stones may enter the common bile duct from the gallbladder but it is not clear if the gallbladder should be removed preventively (prophylactic cholecystectomy) or if a wait-and-see policy (cholecystectomy deferral) would be better. We included 5 randomised trials with 662 participants out of 93 publications identified through the literature searches. The number of deaths was 47 in the wait-and-see group (334 patients) compared with 26 in the prophylactic cholecystectomy group (328 patients). This review of randomised clinical trials suggests that early removal of the gallbladder decreases the risk of death or of complications from gallstones. The number of patients (662) reviewed in this report prevents some of the subgroup analyses from being conclusive. Further clinical trials, particularly of high-risk patients, would solve this problem.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

延遲已接受內視鏡壺腹切開術的病患膽囊切除術的評估.

對於已接受內視鏡術清除總膽管結石的病人,若採取觀察的策略而不做預防性的膽囊切除術,有高達64%的病人並不需要接受膽囊切除術.雖然回溯性世代研究報告顯示,這樣的病人有較高的死亡率,但是否為宿主健康因素引起,或真的是因為“延遲性”膽囊切除術引起,則無從得知.目前而言,比較“延遲性”膽囊切除術和“選擇性/延遲性”膽囊切除術,對於存活率是否有差別的隨機性臨床研究,其檢力(power)仍然不足.

目標

對於已接受膽道鏡壺腹切開術的病人,評估“延遲性”膽囊切除術,以及“選擇性/預防性”膽囊切除術的利弊.

搜尋策略

搜尋Cochrane肝膽群體的控制性研究資料庫(The Cochrane HepatoBiliary Group Controlled Trials Register), Cochrane圖書館控制性研究資料庫(the Cochrane Controlled Trials Register (CENTRAL) in The Cochrane Library), MEDLINE醫學文獻資料庫(1966 – 2007), EMBASE醫藥學文獻資料庫(1980 – 2007),以及科學引用文獻展開資料庫(Science Citation Index Expanded),不用語言限制,直至2007年4月為止.

選擇標準

回顧在不限制是否有資料遮盲,語言,或是不同出版狀態下的隨機臨床試驗,,比較(1)病人接受內視鏡壺腹切開術後,採取“不手術”(觀望)政策,或是(2)預防性膽囊切除術不論是在內視鏡壺腹切開術或總膽管探查術後施行膽囊切除術,以上兩組的結果.

資料收集與分析

我們評估“觀望(延遲性手術)”政策,對於死亡率的影響.次要指標(secondary outcomes)評估膽絞痛,膽道炎,胰臟炎,是否須實行膽道攝影術,是否須實行膽囊切除術,以及實行膽囊切除術的困難度的比例.我們在以固定及隨機效應的模式下,將其相對危險比的資料匯集在一起.

主要結論

經由從文獻搜尋得到93篇發表文章,我們納入5個隨機試驗,共662個病人.結果在“觀望組”共334個病人有47個死亡,而在“預防性膽囊切除組”共328個病人有26個死亡,觀望組“比預防性膽囊切除組”增加了78%的死亡機率(RR 1.78, 95% CI 1.15 to 2.75, P = 0.010).不論各研究的設計,及是否納入高危險群病人,或任一個這五個隨機試驗的病人納入條件下,預防性膽囊切除術的存活利益都是獨立而有意義的。在“觀望組”的病人,有較高的比率有復發性膽絞痛(RR 14.56, 95% CI 4.95 to 42.78, P < 00001),黃疸或膽道炎(RR 2.53, 95% CI 1.09 to 5.87, P = 0.03), 以及重做“經內視鏡逆行性膽胰管攝影術”或其他形式的膽道攝影(RR 2.36, 95% CI 1.29 to 4.32, P = 0.005). 在“觀望組”有35%(共115個病人)最後還是接受膽囊切除術.

作者結論

對於做完膽道鏡壺腹切開術以及總膽管結石清除術後,但是仍有膽囊的病人,應該實施預防性膽囊切除術.

翻譯人

本摘要由臺中榮民總醫院張崇信翻譯。

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

總結

對於做完膽道鏡壺腹切開術以及總膽管結石清除術後,但是仍有膽囊的病人,應該實施預防性膽囊切除術.通常我們會常規的施行膽囊切除術.總膽管結石通常是從膽囊來的,而且通常是有害的.總膽管結石的一般治療為“經內視鏡逆行性膽胰管攝影術,合併壺腹切開術”,意謂經由內視鏡將總膽管的結石摘除. 我們已知可能會有更多的結石從膽囊掉進總膽管內,但是是否因此施行“預防性膽囊切除術”或是施行“延遲性膽囊切除術”則未有定論.經由文獻搜尋找到93個相關的發表,我們納入5個隨機試驗,共662個病人.結果在“觀望組”共334個病人有47個死亡,而在“預防性膽囊切除組”共328個病人有26個死亡.經由隨機臨床試驗的回顧建議:“提早切除膽囊”會降低因膽結石引起的併發症之死亡.這篇由662個病人做出來的結果,會導致一些“次族群分析”無法做出結論.故進一步的臨床試驗特別針對高危險群的病人來解決這樣的疑問,可能有其必要。