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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00505128

Acronym

EEPAB

Enrollment

900

Registered

2007-07-23

Start date

2007-07-31

Completion date

2009-07-31

Last updated

2011-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Pancreatitis

Keywords

Biliary pancreatitis, Bile duct stones, EUS Endoscopic UltraSonography, Endoscopic sphincterotomy, ERCP

Brief summary

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

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

Interventions

PROCEDUREEndoscopic sphincterotomy

procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients cured or consolidated as a function of time	during 12 months

Secondary

Measure	Time frame
overall mortality	during the 36 months
endoscopic procedure-related morbidity and mortality	during the 12months
overall morbidity	during the 36 months
morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)	during the 12 months
economic data	during the 36 months
LOS	during the 12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026