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

Asan Medical Center

Status

Completed

Conditions

Cholecystitis

Treatments

Procedure: EUS-guided gallbladder drainage

Procedure: percutaneous transhepatic gallbladder drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT01146743

EUS_GB1

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)

Exclusion criteria

Age below 18 years
Pregnancy
When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure.
Unstable or unwilling to comply with follow-up
When a perforated viscus is known or suspected
Simultaneously participating in another investigational drug or device study