Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis

Study Overview
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Brief Summary
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The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).

Detailed Description
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The management of Acute biliary pancreatitis (ABP) remains controversial. Although early decompression of the bile duct is deemed potentially beneficial, previous randomised studies failed to show the benefit of early endoscopic sphincterotomy (ES) except in selected cases. However, those studies did not use recent non invasive diagnostic methods such as EUS. Methodology: Patients in the study group undergo EUS followed by ES in case of common bile duct stones within 48 hours of the onset pf symptoms; The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

Official Title
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Randomised Multicenter Trial of Early EUS Followed by Endoscopic Sphincterotomy in Case of Bile Duct Stone vs Conservative Treatment in Severe Biliary Pancreatitis

Conditions
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Pancreatitis Acute Biliary

Intervention / Treatment
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* Procedure: ultrasonography with or not sphincterotomy
* Procedure: Usual procedure


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : age > 18 predicted severe acute biliary pancreatitis (including age > 80, BMI >30, pre-existing organ failure, Modified Glasgow score > 3) timespan between onset and randomization < 48 hrs informed consent signed by patient or liable person in case of emergency Exclusion criteria : non biliary pancreatitis non severe pancreatitis age < 18 timespan between onset and randomization > 48 hrs absence of consent ongoing pregnancy no social security insurance

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 |
| --- | --- |
| Experimental: groupe 1<br>Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone | Procedure: ultrasonography with or not sphincterotomy<br>* Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone<br>|
| Active Comparator: Groupe 2<br>usual procedure | Procedure: Usual procedure<br>* The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between the SOFA score measured at entry in the study (day 0) and at day 8 |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in SOFA score as measured at entry in the study and at day 15 |  | Day 15 | 
| Procedure-related morbidity |  | at Day 15 to 3 months | 
| Overall morbidity |  | at day 15 | 
| Overall mortality |  | at day 15 | 
| Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15 |  | at day 8 and day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, EUS, Pancreatitis biliary, Severe, Interventional endoscopy, Choledocolithiasis