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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-guided | Active Comparator | EUS-guided gallbladder drainage in acute cholecystitis with high risk patients |
|
| percutaneous transhepatic | Active Comparator | percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided gallbladder drainage | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate | Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation. | Within 72 hours from procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Complication was defined as any procedure-related complications during the procedure or within 1 week, including bile leakage, pneumoperitoneum, bleeding, and etc. | Complications during the procedure or within 1 weeks |
| Conversion rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SangSoo Lee, M.D. | Asan Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17767933 | Background | Lee SS, Park DH, Hwang CY, Ahn CS, Lee TY, Seo DW, Lee SK, Kim MW. EUS-guided transmural cholecystostomy as rescue management for acute cholecystitis in elderly or high-risk patients: a prospective feasibility study. Gastrointest Endosc. 2007 Nov;66(5):1008-12. doi: 10.1016/j.gie.2007.03.1080. Epub 2007 Sep 4. |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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|
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| percutaneous transhepatic gallbladder drainage | Procedure | Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route. |
|
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Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy. |
| During laparoscopic cholectstectomy |