Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01146743|
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : March 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cholecystitis||Procedure: EUS-guided gallbladder drainage Procedure: percutaneous transhepatic gallbladder drainage||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||March 2011|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146743
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Study Director:||SangSoo Lee, M.D.||Asan Medical Center|