Cholecystectomy for suspected gallbladder dyskinesia
Editorial Group: Cochrane Hepato-Biliary Group
Published Online: 21 JAN 2009
Assessed as up-to-date: 13 MAR 2008
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
How to Cite
Gurusamy KS, Junnarkar S, Farouk M, Davidson BR. Cholecystectomy for suspected gallbladder dyskinesia. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD007086. DOI: 10.1002/14651858.CD007086.pub2.
- Publication Status: New
- Published Online: 21 JAN 2009
The optimal treatment for patients with suspected biliary dyskinesia is controversial. Some studies found that cholecystectomy produced symptomatic improvement in patients with gallbladder dyskinesia (diagnosed by low gallbladder ejection fraction) while others found no significant benefit. Some studies have shown that gallbladder ejection fraction can discriminate patients who would benefit from cholecystectomy. Other studies have not confirmed this.
The aim of this review was to compare the benefits and harms of cholecystectomy for patients with suspected gallbladder dyskinesia.
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until March 2008.
We considered for inclusion all randomised clinical trials comparing cholecystectomy versus no cholecystectomy on patients with gallbladder dyskinesia.
Data collection and analysis
We collected the data on the characteristics, methodological quality, mortality, number of patients in whom symptoms were improved or cured from the one identified trial. We planned to analyse the data using the fixed-effect and the random-effects models using RevMan Analysis. For each outcome we planned to calculate the risk ratio (RR) with 95% confidence intervals based on intention-to-treat analysis.
We included one trial with 21 patients randomised: 11 to cholecystectomy and 10 to control (no cholecystectomy). This trial was considered to be of high risk of bias as patients were not blinded and the procedure-related morbidity was not reported. There was no mortality in either group. All patients in the cholecystectomy group and only one patient in the control group had improvement in symptoms (P = 0.0001) after a mean follow-up period of 33.6 months.
The evidence for the benefits and harms of cholecystectomy in gallbladder dyskinesia from randomised clinical trials is based on a single small trial at risk of bias. Further randomised clinical trials with improved bias control are necessary to confirm or reject the promising results.
Plain language summary
Need for further randomised clinical trials to assess the role of cholecystectomy in patients with suspected gallbladder dyskinesia
Gallbladder dyskinesia is a motility disorder of the gallbladder (the gallbladder does not contract properly). The disorder is associated with intermittent right upper abdominal pain typically lasting for at least half an hour. The optimal treatment for patients with suspected biliary dyskinesia is controversial. This review evaluates the two alternatives for the diagnosed patient group, that is, cholecystectomy (removal of the gallbladder) versus no intervention. The removal of the gallbladder can be performed by key hole surgery (laparoscopic cholecystectomy) or open surgery (open cholecystectomy). Cholescintigraphy after radiolabeled cholecystokinin (hormone that promotes gallbladder contraction) infusion can measure gallbladder contraction and has been used for the diagnosis of gallbladder dyskinesia. The duration of the cholecystokinin infusion and the cut-off values of ejection fraction (of radioisotope cleared from the gallbladder on contraction) used for the diagnosis of gallbladder dyskinesia are variable, although the most popular cut-off is 35%. Thus, currently, a gallbladder ejection fraction below 35% is considered to be gallbladder dyskinesia. However, there are some doctors who believe that irrespective of ejection fraction, pain related to the gallbladder in the absence of other causes of such pain can be considered gallbladder dyskinesia. One randomised clinical trial including 21 patients found significant cure in pain symptoms after removal of gallbladder (by open surgery) post cholecystectomy (10/11) in patients with a low ejection fraction prior to cholecystectomy compared to those who did not undergo cholecystectomy and had a low ejection fraction (1/10). Further randomised clinical trials of low bias-risk (low risk of systematic error) are necessary to assess the role of cholecystectomy in suspected gallbladder dyskinesia.
人們對於疑似膽囊蠕動不良病人的最佳治療方法存有爭議。 一些研究發現膽囊切除術能夠改善膽囊蠕動不良病人的症狀 (根據膽囊射出率低作出診斷) ，而其他研究發現該手術沒有明顯益處。 一些研究指出膽囊射出率可以區分出可因膽囊切除術受益的病人。其他研究並不認同。
我們搜尋截至2008年3月The Cochrane HepatoBiliary Group Controlled Trials Register, Cochrane Library的Cochrane Central Register of Controlled Trials (CENTRAL)、MEDLINE、 EMBASE和Science Citation Index Expanded。
我們收集所找出的試驗之試驗特性、方法學質量、死亡率、症狀有改善或治癒的病人人數等數據。我們使用RevMan 以固定效果模式和隨機效果模式分析資料。對每次結果，我們計畫以治療意向為基礎，計算風險比率(risk raio RR)，95% CI。
我們包括一個試驗，隨機挑選21位病人: 11人接受膽囊切除術，10個人分配至控制組(無膽囊切除術)。 認為本次試驗的偏誤風險較高，因為沒有對病人採取盲法，也沒有記錄和手術相關的發生率。因此，任一組沒有死亡。在平均追蹤時間33.6個月之後，膽囊切除術組的所有病人和控制組的唯一一個病人改善症狀。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。
未來需要評估膽囊切除術治療疑似膽囊蠕動不良病人的隨機臨床試驗: 膽囊蠕動不良是一種膽囊運動性疾病(膽囊不能正確收縮)。 這種疾病一般和間歇性右上腹疼痛相關，至少持續半個小時。人們對於治療疑似膽囊蠕動不良病人的最佳方法存有爭議。本次文獻回顧評估了對已確診的病人組使用的兩種替代方法，也就是，膽囊切除術 (摘除膽囊)對照無治療法。 透過鎖孔手術(腹腔鏡膽囊切除術)或開腹手術(開腹膽囊切除術)摘除膽囊。在灌注放射標記的膽囊收縮素之後執行膽管閃爍照相術，可以測量膽囊收縮，診斷膽囊蠕動不良。診斷膽囊蠕動不良的因素，比如膽囊收縮素灌注持續期和射出率的臨界值(膽囊收縮清除出來的放射性同位素) 都是可變的，儘管最常用的臨界值是35%。 因此，目前膽囊排放次數低於35%，被認為是膽囊蠕動不良。但是, 一些醫生認為不管射出率如何，除了其他原因以外，由膽囊引起的疼痛也屬於膽囊蠕動不良。一個包括21個病人的隨機臨床試驗發現，與沒有接受膽囊切除術且射出率少(1/10)的病人相比，膽囊摘除之前射出率少且接受膽囊切除術之後的病人，其疼痛的症狀明顯治癒(開腹手術) (10/11)。 需要實施更多偏誤風險低的隨機臨床試驗 (系統誤差風險低) ，評估膽囊切除術治療疑似膽囊蠕動不良的作用。