Prospective randomized trial comparing endoscopic sphincterotomy followed by surgery with surgery alone in good risk patients with choledocholithiasis.

Background: Role of endoscopic sphincterotomy (ES) in high risk patients with choledocholithiasis is established but its role in good risk patients is unclear. Design: A prospective randomized trial of endoscopic sphincterotomy followed by surgery (ES + S) versus surgery alone (SA) in good risk patients with choledocholithiasis. Setting: A tertiary level referral hospital in north India; July 1991 to October 1993. Patients and methods: Thirty three out of 60 patients with choledocholithiasis were found suitable for randomization-16 were randomised to ES+S group and 17 to SA group. Results: Common bile duct clearance was achieved in 11/13 (85%) patients in ES+S group and in 13/15 (87%) in SA group. Major complications occurred in 4/13 (31%) patients in ES+S group and 3/16 (19%) patients in SA group. These differences were not statistically significant, but patients in ES+S group were exposed to morbidity twice, procedure related morbidity of ES being 23%. No significant differences were observed in hospital stay and cost of treatment. Conclusions: Results of this trial do not support use of precholecystectomy ES in good risk patients with choledocholithiasis, since it did not offer any advantage over surgery alone.