A Prospective Randomized Study Comparing Different Dilation Durations for Endoscopic Papillary Balloon Dilatation

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Multicenter Study Comparing Different Dilation Durations During Endoscopic Papillary Balloon Dilatation for Bile Duct Stones.

Conditions
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Choledocholithiasis

Intervention / Treatment
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* Procedure: Endoscopic papillary balloon dilation-5 minutes
* Procedure: Endoscopic papillary balloon dilation-1 minute


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic papillary balloon dilation-5 minutes|nan|
|Procedure: Endoscopic papillary balloon dilation-1 minute|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need of switching to sphincterotomy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of lithotripsy |  |  | 
| post-ERCP complications |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic papillary balloon dilatation, Endoscopic sphincterotomy, Choledocholithiasis, Efficacy, Complication