Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-03-31

Brief Summary

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The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).

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Detailed Description

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The management of Acute biliary pancreatitis (ABP) remains controversial. Although early decompression of the bile duct is deemed potentially beneficial, previous randomised studies failed to show the benefit of early endoscopic sphincterotomy (ES) except in selected cases. However, those studies did not use recent non invasive diagnostic methods such as EUS.

Methodology: Patients in the study group undergo EUS followed by ES in case of common bile duct stones within 48 hours of the onset pf symptoms; The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

Conditions

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Pancreatitis Acute Biliary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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groupe 1

Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone

Group Type EXPERIMENTAL

ultrasonography with or not sphincterotomy

Intervention Type PROCEDURE

Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone

Groupe 2

usual procedure

Group Type ACTIVE_COMPARATOR

Usual procedure

Intervention Type PROCEDURE

The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

Interventions

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ultrasonography with or not sphincterotomy

Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone

Intervention Type PROCEDURE

Usual procedure

The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age \> 18
* predicted severe acute biliary pancreatitis (including age \> 80, BMI \>30, pre-existing organ failure, Modified Glasgow score \> 3)
* timespan between onset and randomization \< 48 hrs
* informed consent signed by patient or liable person in case of emergency

Exclusion Criteria

* non biliary pancreatitis
* non severe pancreatitis
* age \< 18
* timespan between onset and randomization \> 48 hrs
* absence of consent
* ongoing pregnancy
* no social security insurance

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No