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.