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

Not Applicable

Terminated

• Conditions: Pancreatitis Acute Biliary
• Interventions: Procedure: ultrasonography with or not sphincterotomy; Procedure: Usual procedure

• 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2011-06
• Study Completion: 2012-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
groupe 1	ultrasonography with or not sphincterotomy	Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
Groupe 2	Usual procedure	usual procedure

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