Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis (EEPAB2)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Pancreatitis Acute Biliary

Treatments: Procedure: Usual procedure; Procedure: ultrasonography with or not sphincterotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00987428

P080903

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

groupe 1

Experimental group

Description:

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

Treatment:

Procedure: ultrasonography with or not sphincterotomy

Groupe 2

Active Comparator group

Description:

usual procedure

Treatment:

Procedure: Usual procedure