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

NCT ID: NCT00505128

Last Updated: 2011-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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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

Conditions

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Biliary Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type OTHER

Endoscopic sphincterotomy

Intervention Type PROCEDURE

procedure

Interventions

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Endoscopic sphincterotomy

procedure

Intervention Type PROCEDURE

Other Intervention Names

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procedure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department of Clinical Research of developpement

Principal Investigators

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Frederic PRAT, MD,

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Cochin

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P051054

Identifier Type: -

Identifier Source: org_study_id

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