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.
RCT Entities:
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.
Authors: Bobby V M Dasari; Chuan Jin Tan; Kurinchi Selvan Gurusamy; David J Martin; Gareth Kirk; Lloyd McKie; Tom Diamond; Mark A Taylor Journal: Cochrane Database Syst Rev Date: 2013-12-12