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Randomized Controlled Trial
. 2006 Jan;130(1):96-103.
doi: 10.1053/j.gastro.2005.10.015.

Cholecystectomy or gallbladder in situ after endoscopic sphincterotomy and bile duct stone removal in Chinese patients

James Y W Lau  1 , Chon-Kar Leow, Terence M K Fung, Bing-Yee Suen, Ly-Mee Yu, Paul B S Lai, Yuk-Hoi Lam, Enders K W Ng, Wan Yee Lau, Sydney S C Chung, Joseph J Y Sung
Affiliations
Randomized Controlled Trial

Cholecystectomy or gallbladder in situ after endoscopic sphincterotomy and bile duct stone removal in Chinese patients

James Y W Lau et al. Gastroenterology. 2006 Jan.

Abstract

Background & aims: In patients with stones in their bile ducts and gallbladders, cholecystectomy is generally recommended after endoscopic sphincterotomy and clearance of bile duct stones. However, only approximately 10% of patients with gallbladders left in situ will return with further biliary complications. Expectant management is alternately advocated. In this study, we compared the treatment strategies of laparoscopic cholecystectomy and gallbladders left in situ.

Methods: We randomized patients (>60 years of age) after endoscopic sphincterotomy and clearance of their bile duct stones to receive early laparoscopic cholecystectomy or expectant management. The primary outcome was further biliary complications. Other outcome measures included adverse events after cholecystectomy and late deaths from all causes.

Results: One hundred seventy-eight patients entered into the trial (89 in each group); 82 of 89 patients who were randomized to receive laparoscopic cholecystectomy underwent the procedure. Conversion to open surgery was needed in 16 of 82 patients (20%). Postoperative complications occurred in 8 patients (9%). Analysis was by intention to treat. With a median follow-up of approximately 5 years, 6 patients (7%) in the cholecystectomy group returned with further biliary events (cholangitis, n = 5; biliary pain, n = 1). Among those with gallbladders in situ, 21 (24%) returned with further biliary events (cholangitis, n = 13; acute cholecystitis, n = 5; biliary pain, n = 2; and jaundice, n = 1; log rank, P = .001). Late deaths were similar between groups (cholecystectomy, n = 19; gallbladder in situ, n = 11; P = .12).

Conclusions: In the Chinese, cholecystectomy after endoscopic treatment of bile duct stones reduces recurrent biliary events and should be recommended.

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Figures

Figure 1
Figure 1
Participant flow diagram.
Figure 2
Figure 2
Kaplan–Meier estimates of the likelihood that biliary-related events would recur (cholecystectomy group, solid line; gallbladder-in-situ group, dotted line). GB, gallbladder.
Figure 3
Figure 3
Kaplan–Meier estimates of the likelihood of deaths from all causes (cholecystectomy group, solid line; gallbladder-in-situ group, dotted line).
See this image and copyright information in PMC

Comment in

References

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