Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis
NCT ID: NCT00505128
Last Updated: 2011-05-09
Study Results
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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COMPLETED
NA
900 participants
INTERVENTIONAL
2007-07-31
2009-07-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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
Endoscopic sphincterotomy
procedure
Interventions
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Endoscopic sphincterotomy
procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
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
Countries
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Other Identifiers
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P051054
Identifier Type: -
Identifier Source: org_study_id
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