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

Primary Purpose

Pancreatitis Acute Biliary

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasonography with or not sphincterotomy
Usual procedure
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis Acute Biliary focused on measuring ERCP, EUS, Pancreatitis biliary, Severe, Interventional endoscopy, Choledocolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Cochin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

groupe 1

Groupe 2

Arm Description

Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone

usual procedure

Outcomes

Primary Outcome Measures

The difference between the SOFA score measured at entry in the study (day 0) and at day 8

Secondary Outcome Measures

Differences in SOFA score as measured at entry in the study and at day 15
Procedure-related morbidity
Overall morbidity
Overall mortality
Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15

Full Information

First Posted
September 29, 2009
Last Updated
April 29, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00987428
Brief Title
Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis
Acronym
EEPAB2
Official Title
Randomised Multicenter Trial of Early EUS Followed by Endoscopic Sphincterotomy in Case of Bile Duct Stone vs Conservative Treatment in Severe Biliary Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient number of participants
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis Acute Biliary
Keywords
ERCP, EUS, Pancreatitis biliary, Severe, Interventional endoscopy, Choledocolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
groupe 1
Arm Type
Experimental
Arm Description
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
Arm Title
Groupe 2
Arm Type
Active Comparator
Arm Description
usual procedure
Intervention Type
Procedure
Intervention Name(s)
ultrasonography with or not sphincterotomy
Intervention Description
Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone
Intervention Type
Procedure
Intervention Name(s)
Usual procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
The difference between the SOFA score measured at entry in the study (day 0) and at day 8
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Differences in SOFA score as measured at entry in the study and at day 15
Time Frame
Day 15
Title
Procedure-related morbidity
Time Frame
at Day 15 to 3 months
Title
Overall morbidity
Time Frame
at day 15
Title
Overall mortality
Time Frame
at day 15
Title
Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15
Time Frame
at day 8 and day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Prat, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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

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