Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones.
BACKGROUND
Endoscopic papillary balloon dilation (EPBD) has a lower risk of hemorrhage than sphincterotomy and is easier to perform in altered/difficult anatomy. However, the sphincter of Oddi (SO) is only stretched but not cut after EPBD. Therefore, the biliary orifice is less opened, and failed stone extraction with EPBD alone occurs in up to 20% of patients. An uncut SO also may exacerbate pancreatic duct compression from edema after EPBD, and it increases the risk of pancreatitis.


OBJECTIVE
To determine whether a longer duration for EPBD (5-minute vs conventional 1-minute) can further weaken the SO and reduce the rates of failed stone extraction and pancreatitis.


METHODS
Prospective, randomized trial.


METHODS
Two tertiary-care referral centers.


METHODS
This study involved 170 consecutive patients with common bile duct stones.


METHODS
EPBD for 1 minute (n = 86) or 5 minutes (n = 84).


METHODS
Failed stone extraction with EPBD alone and post-ERCP pancreatitis.


RESULTS
Failed stone extraction with EPBD alone was less frequent with 5-minute EPBD (6 of 84, 7.1%) than with 1-minute EPBD (17 of 86, 19.8%), with a relative risk (RR) of 0.36 (P = .024). The risk of pancreatitis was also lower with 5-minute EPBD (4 of 84, 4.8%) than with 1-minute EPBD (13 of 86, 15.1%), with an RR of 0.32 (P = .038). Multivariable logistic regression analyses reaffirmed that 5-minute EPBD reduced the risk of failure with EPBD alone (odds ratio [OR] 0.19, P = .010) and pancreatitis (OR 0.28, P = .035).


CONCLUSIONS
Endoscopists could not be blinded after the dilation durations were randomly assigned.


CONCLUSIONS
Compared with conventional 1-minute EPBD, 5-minute EPBD improves efficacy of stone extraction and reduces the risk of pancreatitis. (


BACKGROUND
NCT00451581).
Liao
Wei-Chih
WC
Department of Internal Medicine, National Taiwan University Hospital, National TaiwanUniversity College of Medicine, Taipei.
Lee
Ching-Tai
CT
Chang
Chi-Yang
CY
Leung
Joseph W
JW
Chen
Jiann-Hwa
JH
Tsai
Ming-Chang
MC
Lin
Jaw-Town
JT
Wu
Ming-Shiang
MS
Wang
Hsiu-Po
HP
D000328:Adult; D000368:Aged; D002404:Catheterization / Q000379:methods*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D004311:Double-Blind Method; D005260:Female; D042882:Gallstones / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D008096:Lithotripsy; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000175:diagnosis / Q000209:etiology; D011446:Prospective Studies; D019233:Retreatment; D012306:Risk; D012307:Risk Factors; D017211:Treatment Failure