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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00505128
First received: July 20, 2007
Last updated: May 6, 2011
Last verified: May 2007
  Purpose

Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.


Condition Intervention
Biliary Pancreatitis
Procedure: Endoscopic sphincterotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Percentage of patients cured or consolidated as a function of time [ Time Frame: during 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall morbidity [ Time Frame: during the 36 months ] [ Designated as safety issue: Yes ]
  • overall mortality [ Time Frame: during the 36 months ] [ Designated as safety issue: Yes ]
  • endoscopic procedure-related morbidity and mortality [ Time Frame: during the 12months ] [ Designated as safety issue: Yes ]
  • LOS [ Time Frame: during the 12 months ] [ Designated as safety issue: Yes ]
  • morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies) [ Time Frame: during the 12 months ] [ Designated as safety issue: Yes ]
  • economic data [ Time Frame: during the 36 months ] [ Designated as safety issue: Yes ]

Enrollment: 900
Study Start Date: July 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography
Procedure: Endoscopic sphincterotomy
procedure
Other Name: procedure

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505128

Locations
France
Hopital Cochin
Paris, France, 75679
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Frederic PRAT, MD, Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Cecile jourdain, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00505128     History of Changes
Other Study ID Numbers: P051054
Study First Received: July 20, 2007
Last Updated: May 6, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Biliary pancreatitis
Bile duct stones
EUS Endoscopic UltraSonography
Endoscopic sphincterotomy
ERCP

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014