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CompletedNCT00505128EEPABUpdated May 9, 2011

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

An interventional study of Endoscopic sphincterotomy in Biliary Pancreatitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-09.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Biliary Pancreatitis

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Keywords

  • Biliary pancreatitis
  • Bile duct stones
  • EUS Endoscopic UltraSonography
  • Endoscopic sphincterotomy
  • ERCP
03

In context

Cholecystolithiasis

244 studies on the registry are indexed under Cholecystolithiasis; 26 are open to participants now.

This study's enrollment of 900 is above the median of 100 across 165 interventional studies indexed under Cholecystolithiasis.

Browse Cholecystolithiasis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,578 studies on the registry; 1,030 are open to participants now.

Browse Assistance Publique - Hôpitaux de Paris studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
900 participants (actual)

Study arms

  • Other
    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

Interventions

  • ProcedureEndoscopic sphincterotomy

    procedure

    Also known as: procedure

06

What researchers measure

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

07

Study locations

1 site
  • Hopital Cochin
    Paris, 75679, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00505128
Lead sponsor
Assistance Publique - Hôpitaux de Paris
First posted
Jul 23, 2007
Start date
Jul 2007
Primary completion
Jul 2009
Completion
Jul 2009
Last update
May 9, 2011

Study contacts

Frederic PRAT, MD,
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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