Elsevier

The Lancet

Volume 360, Issue 9335, 7 September 2002, Pages 761-765
The Lancet

Articles
Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial

https://doi.org/10.1016/S0140-6736(02)09896-3Get rights and content

Summary

Background

Patients who undergo endoscopic sphincterotomy for common bile-duct stones, who have residual gallbladder stones, are referred for laparoscopic cholecystectomy. However, only 10% of patients who do not have this operation are reported to develop recurrent biliary symptoms. We aimed to assess whether a wait-and-see policy is justified.

Methods

We did a prospective, randomised, multicentre trial in 120 patients (age 18–80 years) who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones. Patients were randomly allocated to wait and see (n=64) or laparoscopic cholecystectomy (56). Primary outcome was reoccurrence of at least one biliary event during 2-year follow-up, and secondary outcomes were complications of cholecystectomy and quality of life. Analysis was by intention to treat.

Findings

12 patients were lost to follow-up immediately. Of 59 patients allocated to wait and see, 27 (47%) had recurrent biliary symptoms compared with one (2%) of 49 patients after laparoscopic cholecystectomy (relative risk 22·42, 95% CI 3·16–159·14, p<0·0001). 22 (81%) of 27 patients underwent cholecystectomy, mainly for biliary pain (n=13) or acute cholecystitis (7). Conversion rate to open surgery was 55% in patients allocated to wait and see who underwent cholecystectomy compared with 23% in those who were allocated laparoscopic cholecystectomy (p=0·0104). Morbidity was 32% versus 14% (p=0·1048), and median hospital stay was 9 versus 7 days. Quality of life returned to normal within 3 months after either treatment policy.

Interpretation

A wait-and-see policy after endoscopic sphincterotomy in combined cholecystodocholithiasis cannot be recommended as standard treatment, since 47% of expectantly managed patients developed at least one recurrent biliary event and 37% needed cholecystectomy. No major biliary complications arose, but conversion rate was high.

Introduction

Endoscopic sphincterotomy is widely accepted as the treatment of choice for patients with common bile-duct stones.1, 2, 3 Stone extraction is successful in up to 97% of patients,3, 4, 5 with a procedure-related morbidity of 5·8% and a mortality rate of 0·2%.3 Whether subsequent laparoscopic cholecystectomy is indicated in patients with concomitant gallbladder stones—to prevent biliary complications such as biliary colics, acute cholecystitis, or recurrent common bile-duct stones with cholangitis or biliary pancreatitis—remains a matter of debate. In several retrospective and prospective non-randomised studies, researchers have shown that only 4–12% of patients who are not operated on develop biliary complications during follow-up.1, 2, 4, 6, 7, 8

Risk factors for development of at least one recurrent biliary event after endoscopic sphincterotomy have been reported, such as multiple small gallbladder stones, a non-patent cystic duct, cholangitis upon presentation, and young age.9 However, reports are controversial, and the decision whether to operate or not seems largely empirical. In an evaluation of all patients who had been referred for endoscopic sphincterotomy for common bile-duct stones,10 referring surgeons were more likely to advise subsequent cholecystectomy, whereas gastroenterologists managed more patients expectantly, though there was no difference in age and comorbidity between both groups.

To assess whether a wait-and-see policy after endoscopic sphincterotomy is justified, we did a randomised trial in which we compared elective laparoscopic cholecystectomy with a wait-and-see policy after successful endoscopic sphincterotomy and extraction of common bile-duct stones.

Section snippets

Patients

We recruited patients from the Departments of Surgery and Gastroenterology of the Academic Medical Center, Amsterdam, and from eight other Dutch Community Hospitals. All patients between 18 and 80 years of age, who underwent successful endoscopic sphincterotomy and extraction of common bile-duct stones and who had radiologically proven stones in the gallbladder, were eligible for the trial. We excluded patients who were not fit for surgery (ie, ASA IV and V). We asked all consecutive patients

Results

Between September, 1995, and April, 1999, 120 patients were recruited (figure 1). 56 patients were randomly allocated to laparoscopic cholecystectomy and 64 to a wait-and-see policy. Since initial endoscopic sphincterotomy was often done in an acute setting outside regular working hours, information about patients who were eligible for the trial but who were not randomly allocated was incomplete. However, 66 of 120 patients were randomly allocated in one hospital (Academic Medical Center);

Discussion

We showed that 47% (27/59) of expectantly managed patients (wait and see) developed at least one recurrent biliary event after sphincterotomy during 2 years of follow-up, compared with 2% (1/49) of patients who underwent laparoscopic cholecystectomy. The absolute risk reduction of laparoscopic cholecystectomy is 45%. Thus, the low recurrence rate (5–12%) of biliary-related events during follow-up after sphincterotomy, with gallbladder in situ, as reported in many retrospective studies with

References (20)

There are more references available in the full text version of this article.

Cited by (0)

View full text