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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients

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 transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.

Detailed Summary:

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.


Sponsor: Asan Medical Center

Current Primary Outcome: Clinical response rate [ Time Frame: Within 72 hours from procedure ]

Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complication rate [ Time Frame: Complications during the procedure or within 1 weeks ]
    Complication was defined as any procedure-related complications during the procedure or within 1 week, including bile leakage, pneumoperitoneum, bleeding, and etc.
  • Conversion rate [ Time Frame: During laparoscopic cholectstectomy ]
    Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy.


Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: June 9, 2010
Date Started: June 2010
Date Completion:
Last Updated: March 16, 2011
Last Verified: March 2011