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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
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.
Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
Asan Medical Center
Seoul, South Korea
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
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