A Prospective Randomized Multicenter Study Comparing Different Dilation Durations During Endoscopic Papillary Balloon Dilatation for Bile Duct Stones.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- need of switching to sphincterotomy
Study Overview
Brief Summary
Endoscopic papillary balloon dilation is as effective as sphincterotomy in treating bile duct stone. However, a need to switch to sphincterotomy is noted in about 20% of cases receiving dilation for lithotripsy. It is hypothesized that a longer dilation duration (5 min. vs. 1 min.) can decrease the need of switching to sphincterotomy.
Detailed Description
Endoscopic papillary balloon dilatation (EPBD) has been proposed as an alternative to endoscopic sphincterotomy (EST) for endoscopic treatment of common bile duct (CBD) stones. EPBD is as effective as EST in stone clearance with a lower risk of hemorrhage, and may preserve the function of sphincter of Oddi. However, it has been reported that about 20% of patients undergoing EPBD need EST as a rescue procedure for lithotripsy. A longer dilation duraton of 5 mintues as opposed to 1 minute has been proposed to decrease oozing after dilation and facilitate lithotripsy, and it is hypothesized that it will reduce the need of switching to EST.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing endoscopic retrograde cholangiopancreatography for choledocholithiasis
Exclusion Criteria
- •Consent not obtained.
- •No apparent stone.
- •Intradiverticular papilla.
- •Prior EST.
- •Bile duct stricture.
- •Pancreatic or biliary malignant disorders.
- •Intrahepatic stones.
- •Active acute pancreatitis.
- •Sphincter of Oddi dysfunction.
- •Pregnancy.
- •Primary sclerosing cholangitis or choledochocyst.
- •Previous biliary surgery other than cholecystectomy.
- •Stone impaction at ampulla.
- •Precut for cannulation.
Outcomes
Primary Outcomes
need of switching to sphincterotomy
Secondary Outcomes
- efficacy of lithotripsy
- post-ERCP complications