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

Study Overview
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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

Official Title
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Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study

Conditions
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Biliary Pancreatitis

Intervention / Treatment
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* Procedure: Endoscopic sphincterotomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography | Procedure: Endoscopic sphincterotomy<br>* procedure<br>* Other names: procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients cured or consolidated as a function of time |  | during 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary pancreatitis, Bile duct stones, EUS Endoscopic UltraSonography, Endoscopic sphincterotomy, ERCP