NCT00505128

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 9, 2011

Status Verified

May 1, 2007

Enrollment Period

2 years

First QC Date

July 20, 2007

Last Update Submit

May 6, 2011

Conditions

Biliary Pancreatitis

Keywords

Biliary pancreatitisBile duct stonesEUS Endoscopic UltraSonographyEndoscopic sphincterotomyERCP

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients cured or consolidated as a function of time

    during 12 months

Secondary Outcomes (6)

  • overall morbidity

    during the 36 months

  • overall mortality

    during the 36 months

  • endoscopic procedure-related morbidity and mortality

    during the 12months

  • LOS

    during the 12 months

  • morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)

    during the 12 months

  • +1 more secondary outcomes

Study Arms (1)

1

OTHER

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

Endoscopic sphincterotomyPROCEDURE

procedure

Also known as: procedure
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non biliary pancreatitis
  • Age \< 18
  • Timespan between onset of symptoms and randomization \>72h
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75679, France

Location

MeSH Terms

Conditions

Cholecystolithiasis

Interventions

Sphincterotomy, EndoscopicMethods

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeEndoscopy, GastrointestinalEndoscopy, Digestive SystemEndoscopyMinimally Invasive Surgical ProceduresSphincterotomyMyotomyInvestigative Techniques

Study Officials

  • Frederic PRAT, MD,

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 23, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 9, 2011

Record last verified: 2007-05

Locations

FR(1)