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Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis (EEPAB)

Primary Purpose

Biliary Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endoscopic sphincterotomy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Pancreatitis focused on measuring Biliary pancreatitis, Bile duct stones, EUS Endoscopic UltraSonography, Endoscopic sphincterotomy, ERCP

Eligibility Criteria

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

Inclusion Criteria:

  • Previous medical examination
  • Age over 18
  • Acute biliary pancreatitis
  • Timespan between onset of symptoms and randomization <72h
  • No involvement in another clinical study
  • Informed consent obtained

Exclusion Criteria:

  • Non biliary pancreatitis
  • Age < 18
  • Timespan between onset of symptoms and randomization >72h
  • No follow-up possible beyond 3 months after inclusion
  • Ongoing pregnancy
  • No informed consent
  • No health insurance affiliation
  • Involvement in another clinical study
  • Incapacity to understand subject information
  • Counter indication of MRI examination if echo-endoscopy is not available

Sites / Locations

  • Hopital Cochin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography

Outcomes

Primary Outcome Measures

Percentage of patients cured or consolidated as a function of time

Secondary Outcome Measures

overall morbidity
overall mortality
endoscopic procedure-related morbidity and mortality
LOS
morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)
economic data

Full Information

First Posted
July 20, 2007
Last Updated
May 6, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00505128
Brief Title
Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis
Acronym
EEPAB
Official Title
Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.
Detailed Description
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study. Main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography. Prospective multicenter randomized controlled study with direct patient benefit

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Pancreatitis
Keywords
Biliary pancreatitis, Bile duct stones, EUS Endoscopic UltraSonography, Endoscopic sphincterotomy, ERCP

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography
Intervention Type
Procedure
Intervention Name(s)
Endoscopic sphincterotomy
Other Intervention Name(s)
procedure
Intervention Description
procedure
Primary Outcome Measure Information:
Title
Percentage of patients cured or consolidated as a function of time
Time Frame
during 12 months
Secondary Outcome Measure Information:
Title
overall morbidity
Time Frame
during the 36 months
Title
overall mortality
Time Frame
during the 36 months
Title
endoscopic procedure-related morbidity and mortality
Time Frame
during the 12months
Title
LOS
Time Frame
during the 12 months
Title
morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)
Time Frame
during the 12 months
Title
economic data
Time Frame
during the 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previous medical examination Age over 18 Acute biliary pancreatitis Timespan between onset of symptoms and randomization <72h No involvement in another clinical study Informed consent obtained Exclusion Criteria: Non biliary pancreatitis Age < 18 Timespan between onset of symptoms and randomization >72h No follow-up possible beyond 3 months after inclusion Ongoing pregnancy No informed consent No health insurance affiliation Involvement in another clinical study Incapacity to understand subject information Counter indication of MRI examination if echo-endoscopy is not available
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic PRAT, MD,
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France

12. IPD Sharing Statement

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Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis

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