Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
|Cholecystitis||Procedure: EUS-guided gallbladder drainage Procedure: percutaneous transhepatic gallbladder drainage|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients|
- 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.
- 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.
|Study Start Date:||June 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: EUS-guided
EUS-guided gallbladder drainage in acute cholecystitis with high risk patients
Procedure: EUS-guided gallbladder drainage
EUS-guided gallbladder drainage was performed with a linear-array echoendoscope. The initial puncture was performed at the antrum of the stomach or bulb of the duodenum and was chosen to access the gallbladder body or neck and avoid visible vessels. After removal of the needle, a 6F or 7F bougie were inserted and then removed to dilate the tract. Afterward, nasobiliary drainage tube or stent was placed.
Other Name: EUS-guided transmural drainage
Active Comparator: percutaneous transhepatic
percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients
Procedure: percutaneous transhepatic gallbladder drainage
Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
Other Name: percutaneous cholecystostomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146743
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Study Director:||SangSoo Lee, M.D.||Asan Medical Center|