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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00505128
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment
Biliary Pancreatitis Procedure: Endoscopic sphincterotomy

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2007
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percentage of patients cured or consolidated as a function of time [ Time Frame: during 12 months ]

Secondary Outcome Measures :
  1. overall morbidity [ Time Frame: during the 36 months ]
  2. overall mortality [ Time Frame: during the 36 months ]
  3. endoscopic procedure-related morbidity and mortality [ Time Frame: during the 12months ]
  4. LOS [ Time Frame: during the 12 months ]
  5. morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies) [ Time Frame: during the 12 months ]
  6. economic data [ Time Frame: during the 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cecile jourdain, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00505128     History of Changes
Other Study ID Numbers: P051054
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: May 2007

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