Cholecystitis
Conditions
Keywords
EUS-guided transmural cholecystostomy
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 description
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.
Interventions
PROCEDUREEUS-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.
PROCEDUREpercutaneous transhepatic gallbladder drainage
Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)
Exclusion criteria
* Age below 18 years * Pregnancy * When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure. * Unstable or unwilling to comply with follow-up * When a perforated viscus is known or suspected * Simultaneously participating in another investigational drug or device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | 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 | During laparoscopic cholectstectomy | Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy. |
Countries
South Korea
Outcome results
None listed