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

Assistance Publique - Hôpitaux de Paris900 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

900

Conditions

Biliary Pancreatitis

Interventions

Endoscopic sphincterotomyPROCEDURE

procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Cochin

Paris, France

Outcomes

Primary Outcomes

Percentage of patients cured or consolidated as a function of time

Time frame: during 12 months

Secondary Outcomes

overall morbidity

Time frame: during the 36 months

overall mortality

Time frame: during the 36 months

endoscopic procedure-related morbidity and mortality

Time frame: during the 12months

LOS

Time frame: during the 12 months

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

Time frame: during the 12 months

economic data

Time frame: during the 36 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.