Endoscopic sphincterotomy and endoscopic papillary balloon dilatation for bile duct stones: A prospective randomized controlled multicenter trial.
BACKGROUND
Endoscopic papillary balloon dilatation may be an alternative to endoscopic sphincterotomy in the treatment of bile duct stones. However, there is a controversy as to the effectiveness and safety of endoscopic papillary balloon dilatation.


METHODS
Two hundred eighty-two patients with bile duct stones were enrolled and randomized to an endoscopic sphincterotomy or endoscopic papillary balloon dilatation group. The success rate for duct clearance as well as the frequency and types of complications were evaluated prospectively. Endoscopic sphincterotomy was performed in a standard manner. Endoscopic papillary balloon dilatation was carried out with gradual inflation of a 4-, 6-, or 8-mm diameter balloon.


RESULTS
Complete duct clearance was achieved in 100% in the endoscopic sphincterotomy group and 99.3% in the endoscopic papillary balloon dilatation group (not significant). Complications occurred in 11.8% of patients in the endoscopic sphincterotomy group and 14.5% of those in the endoscopic papillary balloon dilatation group (not significant). No complication was severe; there was no mortality. The frequency of acute pancreatitis was higher in the endoscopic papillary balloon dilatation group than the endoscopic sphincterotomy group (respectively, 10.9% vs. 2.8%; p < 0.045). Hemorrhage occurred only in the endoscopic sphincterotomy group.


CONCLUSIONS
Endoscopic sphincterotomy and endoscopic papillary balloon dilatation were approximately equal in terms of successful clearance of bile duct stones. They were also similar with respect to overall complications. Endoscopic papillary balloon dilatation is an alternative to endoscopic sphincterotomy as a treatment of bile duct stones.
Fujita
Naotaka
N
Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan.
Maguchi
Hiroyuki
H
Komatsu
Yutaka
Y
Yasuda
Ichiro
I
Hasebe
Osamu
O
Igarashi
Yoshinori
Y
Murakami
Akihiko
A
Mukai
Hidekazu
H
Fujii
Tsuneshi
T
Yamao
Kenji
K
Maeshiro
Kensei
K
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization / Q000009:adverse effects / Q000379:methods*; D002769:Cholelithiasis / Q000175:diagnosis / Q000601:surgery* / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000503:physiopathology; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000503:physiopathology; D011336:Probability; D018570:Risk Assessment; D012720:Severity of Illness Index; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome