Background Endoscopic sphincterotomy is commonly used to remove bile-d
uct stones and to treat other problems. We prospectively investigated
risk factors for complications of this procedure and their outcomes. M
ethods We studied complications that occurred within 30 days of endosc
opic biliary sphincterotomy in consecutive patients treated at 17 inst
itutions in the United States and Canada from 1992 through 1994. Resul
ts Of 2347 patients, 229 (9.8 percent) had a complication, including p
ancreatitis in 127 (5.4 percent) and hemorrhage in 48 (2.0 percent). T
here were 55 deaths from all causes within 30 days; death was directly
or indirectly related to the procedure in 10 cases. Of five significa
nt risk factors for complications identified in a multivariate analysi
s, two were characteristics of the patients (suspected dysfunction of
the sphincter of Oddi as an indication for the procedure and the prese
nce of cirrhosis) and three were related to the endoscopic technique (
difficulty in cannulating the bile duct, achievement of access to the
bile duct by ''precut'' sphincterotomy, and use of a combined percutan
eous-endoscopic procedure). The overall risk of complications was not
related to the patient's age, the number of coexisting illnesses, or t
he diameter of the bile duct. The rate of complications was highest wh
en the indication for the procedure was suspected dysfunction of the s
phincter of Oddi (21.7 percent) and lowest when the indication was rem
oval of bile-duct stones within 30 days of laparoscopic cholecystectom
y (4.9 percent). As compared with those who performed fewer procedures
, endoscopists who performed more than one sphincterotomy per week had
lower rates of complications (8.4 percent vs. 11.1 percent, P=0.03).
Conclusions The rate of complications after endoscopic biliary sphinct
erotomy can vary widely in different circumstances and is primarily re
lated to the indication for the procedure and to endoscopic technique,
rather than to the age or general medical condition of the patient.