An interventional study of ultrasonography with or not sphincterotomy and Usual procedure in Pancreatitis Acute Biliary, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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).
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.
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's enrollment of 27 is below the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion criteria :
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
Procedure: ultrasonography with or not sphincterotomy
usual procedure
Procedure: Usual procedure
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
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.
The difference between the SOFA score measured at entry in the study (day 0) and at day 8
Time frame: Day 8
Differences in SOFA score as measured at entry in the study and at day 15
Time frame: Day 15
Procedure-related morbidity
Time frame: at Day 15 to 3 months
Overall morbidity
Time frame: at day 15
Overall mortality
Time frame: at day 15
Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15
Time frame: at day 8 and day 15
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris