Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis
- Conditions
- Pancreatitis Acute Biliary
- Registration Number
- NCT00987428
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The difference between the SOFA score measured at entry in the study (day 0) and at day 8 Day 8
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hopital Cochin
🇫🇷Paris, France
Hopital Cochin🇫🇷Paris, France