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

2014-07-24 14:11:21 | BioPortfolio

Summary

The primary purpose of this trial is to determine whether an early 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).

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Predicted Severe Acute Biliary Pancreatitis

Intervention

ultrasonography with or not sphincterotomy, Usual procedure

Location

Hopital Cochin
Paris
France
75014

Status

Recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:21-0400

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Ultrasonography of internal organs using an ultrasound transducer sometimes mounted on a fiberoptic endoscope. In endosonography the transducer converts electronic signals into acoustic pulses or continuous waves and acts also as a receiver to detect reflected pulses from within the organ. An audiovisual-electronic interface converts the detected or processed echo signals, which pass through the electronics of the instrument, into a form that the technologist can evaluate. The procedure should not be confused with ENDOSCOPY which employs a special instrument called an endoscope. The "endo-" of endosonography refers to the examination of tissue within hollow organs, with reference to the usual ultrasonography procedure which is performed externally or transcutaneously.

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