An interventional study of EUS-guided gallbladder drainage and percutaneous transhepatic gallbladder drainage in Cholecystitis, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-17.
Sponsored by Asan Medical Center · Not applicable, Interventional, and Treatment
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.
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.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 59 is below the median of 86 across 167 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
EUS-guided gallbladder drainage in acute cholecystitis with high risk patients
Procedure: EUS-guided gallbladder drainage
percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients
Procedure: percutaneous transhepatic 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.
Also known as: EUS-guided transmural drainage
Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
Also known as: percutaneous cholecystostomy
Clinical response rate
Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.
Time frame: Within 72 hours from procedure
Complication rate
Complication was defined as any procedure-related complications during the procedure or within 1 week, including bile leakage, pneumoperitoneum, bleeding, and etc.
Time frame: Complications during the procedure or within 1 weeks
Conversion rate
Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy.
Time frame: During laparoscopic cholectstectomy
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Asan Medical Center