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

Not Applicable

• Conditions: Choledocholithiasis

• Registration Number: NCT00451581
• Lead Sponsor: National Taiwan University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2006-10
• Study Start: 2007-01
• Study First Submitted: 2007-03-22
• Study First Submitted QC: 2007-03-22
• Last Update Submitted: 2007-03-22
• Study First Posted: 2007-03-23
• Last Update Posted: 2007-03-23
• Study Completion: 2008-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients undergoing endoscopic retrograde cholangiopancreatography for choledocholithiasis

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
need of switching to sphincterotomy

Secondary Outcome Measures

Name	Time	Method
efficacy of lithotripsy
post-ERCP complications

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan