Na endoscopische sfincterotomie voor choledochusstenen meer recidiefklachten bij afwachtend beleid dan bij geplande laparoscopische cholecystectomie; gerandomiseerde klinische trial

To determine whether a wait-and-see approach is justified in patients who undergo successful endoscopic sphincterotomy for common bile duct stones, with residual gallbladder stones.

Design

Prospective, randomised, multicentre clinical trial.

Method

A total of 120 patients (aged 18-80) who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones, were randomly allocated to a wait-and-see approach (n = 64) or laparoscopic cholecystectomy (n = 56). The primary outcome was the occurrence of at least one biliary event during a 2-year follow-up, and secondary outcomes were complications of cholecystectomy and quality of life. Analysis was according to the intention-to-treat principle.

Results

Of the 120 patients randomised, 12 were lost to follow-up immediately. Of the 59 patients allocated to a wait-and-see approach, 27 (47) had recurrent biliary symptoms compared with 1 of the 49 patients (2) after planned laparoscopic cholecystectomy (relative risk for complaints in the case of a wait-and-see approach: 22.42; (95 CI 3.16-159.14; p < 0.0001). Twenty-two (81) of the 27 patients later underwent cholecystectomy, mainly for biliary pain (n = 13) or acute cholecystitis (n = 7). The conversion rate to open cholecystectomy was 55 in patients allocated to the wait-and-see approach group compared with 23 in those allocated to the laparoscopic cholecystectomy group (p = 0.0104). The morbidity was 32 versus 14 (p = 0.1048) respectively, and the median hospital stay was 9 versus 7 days respectively. Quality of life returned to normal within 3 months after either treatment policy.

Conclusion

A wait-and-see approach after endoscopic sphincterotomy in patients with combined cholecystodocholithiasis cannot be recommended as standard treatment, since 47 of patients treated with a wait-and-see approach developed at least one recurrent biliary event within 2 years and 37 still needed cholecystectomy. No major biliary complications arose, but the conversion rate was high.