Status:
COMPLETED
Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
Lead Sponsor:
Asan Medical Center
Conditions:
Cholecystitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 tra...
Detailed 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...
Eligibility Criteria
Inclusion
- high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01146743
Start Date
June 1 2010
End Date
March 1 2011
Last Update
March 17 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736