Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones.
OBJECTIVE
Endoscopic retrograde cholangiopancreatography is commonly performed to remove bile duct stones. The aim of this study was to determine short-term outcomes of endoscopic balloon dilation of the sphincter of Oddi compared with sphincterotomy for stone extraction.


METHODS
A randomized, controlled multicenter study of 117 patients assigned to dilation and 120 to sphincterotomy was performed in a spectrum of clinical and academic practices.


RESULTS
Characteristics of the patients, procedures, and endoscopists were similar except that dilation patients were younger. Procedures were successful in 97.4% and 92.5% of the dilation and sphincterotomy patients, respectively. Overall morbidity occurred in 17.9% and 3.3% ( P < .001; difference, 14.6; 95% confidence interval, 7-22.3) and severe morbidity, including 2 deaths, in 6.8% and 0%( P < .004; difference, 6.8; 95% confidence interval, 2.3-11.4) for dilation and sphincterotomy, respectively. Complications for dilation and sphincterotomy, respectively, included: pancreatitis, 15.4% and .8% ( P < .001; difference, 14.6; 95% confidence interval, 7.8-21.3); cystic duct fistula, 1.7% and 0%; cholangitis, .9% and .8%; perforation, 0% and .8%; and cholecystitis, 0% and .8%. There were 2 deaths (1.7%) due to pancreatitis following dilation and none with sphincterotomy. The study was terminated at the first interim analysis. Dilation patients required significantly more invasive procedures, longer hospital stays, and longer time off from normal activities.


CONCLUSIONS
In a broad spectrum of patients and practices, endoscopic balloon dilation compared with sphincterotomy for biliary stone extraction is associated with increased short-term morbidity rates and death due to pancreatitis. Balloon dilation of the sphincter of Oddi for stone extraction should be avoided in routine practice.
Disario
James A
JA
Division of Gastroenterology, Hepatology and Nutrition, University of Utah Health Science Center, Salt Lake City, UT 84132, USA. james.discario@hsc.utah.edu
Freeman
Martin L
ML
Bjorkman
David J
DJ
Macmathuna
Padraic
P
Petersen
Bret T
BT
Jaffe
Philip E
PE
Morales
Thomas G
TG
Hixson
Lee J
LJ
Sherman
Stuart
S
Lehman
Glen A
GA
Jamal
M Mazen
MM
Al-Kawas
Firas H
FH
Khandelwal
Mukul
M
Moore
Joseph P
JP
Derfus
Gregory A
GA
Jamidar
Priya A
PA
Ramirez
Francisco C
FC
Ryan
Michael E
ME
Woods
Karen L
KL
Carr-Locke
David L
DL
Alder
Stephen C
SC
D001652:Bile Ducts / Q000601:surgery*; D002404:Catheterization / Q000379:methods*; D002763:Cholecystectomy; D005260:Female; D005500:Follow-Up Studies; D042882:Gallstones / Q000601:surgery* / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome