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NCT Number: NCT00505128

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

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

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Key information

Conditions

Biliary Pancreatitis Biliary Tract Diseases Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Cochin

Paris, 75679, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Sphincterotomy

Procedure

procedure

Other names: procedure

Primary outcomes

  1. Percentage of patients cured or consolidated as a function of time

    Time frame: during 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study

Acronym: EEPAB

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 23, 2007
Registry last updated
May 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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