Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis

Not Applicable

Completed

• Conditions: Biliary Pancreatitis
• Interventions: Procedure: Endoscopic sphincterotomy

• Registration Number: NCT00505128
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.

Detailed Description

Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.

Main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography.

Prospective multicenter randomized controlled study with direct patient benefit

Study Timeline

• Status Verified: 2007-05
• Study Start: 2007-07
• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2011-05-06
• Last Update Posted: 2011-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Previous medical examination
• Age over 18
• Acute biliary pancreatitis
• Timespan between onset of symptoms and randomization <72h
• No involvement in another clinical study
• Informed consent obtained

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Exclusion Criteria

• Non biliary pancreatitis
• Age < 18
• Timespan between onset of symptoms and randomization >72h
• No follow-up possible beyond 3 months after inclusion
• Ongoing pregnancy
• No informed consent
• No health insurance affiliation
• Involvement in another clinical study
• Incapacity to understand subject information
• Counter indication of MRI examination if echo-endoscopy is not available

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Endoscopic sphincterotomy	to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography

Primary Outcome Measures

Name	Time	Method
Percentage of patients cured or consolidated as a function of time	during 12 months

Secondary Outcome Measures

Name	Time	Method
overall morbidity	during the 36 months
overall mortality	during the 36 months
endoscopic procedure-related morbidity and mortality	during the 12months
LOS	during the 12 months
morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)	during the 12 months
economic data	during the 36 months

Trial Locations

Locations (1)

Hopital Cochin; 🇫🇷 Paris, France