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.


METHODS
A prospective randomized trial of endoscopic sphincterotomy followed by surgery (ES + S) versus surgery alone (SA) in good risk patients with choledocholithiasis.


METHODS
A tertiary level referral hospital in north India; July 1991 to October 1993.


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.
Kapoor
R
R
Department of Surgical Gastroenterology, Sanjay Gandhi Post graduate Institute of Medical Sciences, Lucknow, India.
Kaushik
S P
SP
Saraswat
V A
VA
Choudhuri
G
G
Sikora
S S
SS
Saxena
R
R
Kapoor
V K
VK
D000328:Adult; D002763:Cholecystectomy; D042882:Gallstones / Q000601:surgery*; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D016717:Sphincterotomy, Endoscopic