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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Biliary Pancreatitis

Treatments: Procedure: Endoscopic sphincterotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00505128

P051054

Details and patient eligibility

About

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

Full 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

Enrollment: 900 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 1 patient group

1

Other group

Description:

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

Treatment:

Procedure: Endoscopic sphincterotomy