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Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients

2014-08-27 03:12:49 | BioPortfolio

Summary

The investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.

Description

The primary outcome is to compare clinical resolution rate of EUS-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage in acute cholecystitis patients with high risk.

The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.

Study Design

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

Conditions

Cholecystitis

Intervention

EUS-guided gallbladder drainage, percutaneous transhepatic gallbladder drainage

Location

Asan Medical Center
Seoul
Korea, Republic of
138-736

Status

Not yet recruiting

Source

Asan Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:49-0400

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Medical and Biotech [MESH] Definitions

A variant of acute cholecystitis with inflammation of the GALLBLADDER that is characterized by the pockets of gas in the gallbladder wall. It is due to secondary infection caused by gas-forming organisms, and has a high risk of perforation.

Establishment of an opening into the gallbladder either for drainage or surgical communication with another part of the digestive tract, usually the duodenum or jejunum.

A process whereby bile is delivered from the gallbladder into the duodenum. The emptying is caused by both contraction of the gallbladder and relaxation of the sphincter mechanism at the choledochal terminus.

Inflammation of the GALLBLADDER wall in the absence of GALLSTONES.

Tumors or cancer of the gallbladder.

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