Cholecystectomy deferral in patients with endoscopic sphincterotomy
Editorial Group: Cochrane Hepato-Biliary Group
Published Online: 17 OCT 2007
Assessed as up-to-date: 27 JUL 2007
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
- Publication Status: Edited (no change to conclusions)
- Published Online: 17 OCT 2007
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.
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.
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.
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.
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.
Prophylactic cholecystectomy should be offered to patients whose gallbladders remain in-situ after endoscopic sphincterotomy and common bile duct clearance.
Plain language summary
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.
搜尋Cochrane肝膽群體的控制性研究資料庫(The Cochrane HepatoBiliary 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.
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.
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。