Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis (EEPAB2)

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hôpital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: groupe 1
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
Procedure: ultrasonography with or not sphincterotomy
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
Active Comparator: Groupe 2
usual procedure
Procedure: Usual procedure
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in SOFA score as measured at entry in the study and at day 15
Time Frame: Day 15
Day 15
Procedure-related morbidity
Time Frame: at Day 15 to 3 months
at Day 15 to 3 months
Overall morbidity
Time Frame: at day 15
at day 15
Overall mortality
Time Frame: at day 15
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
at day 8 and day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Frederic Prat, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimated)

October 1, 2009

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P080903

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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