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| Name | Class |
|---|---|
| American Society for Gastrointestinal Endoscopy | OTHER |
| Tokyo Medical University | OTHER |
| Kinki University | OTHER |
| University of Barcelona |
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Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in treatment of this condition has been demonstrated but how the two procedures compare to one another is uncertain.
The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-guided gallbladder drainage | Active Comparator |
| |
| Percutaneous cholecystomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided gallbladder drainage (EGBD) | Procedure | The gallbladder would be identified by a linear echoendoscope (EUS) and a suitable puncture site in the stomach or the duodenum without intervening blood vessels would be located. The gallbladder would be punctured with a 19-gauge needle and a guidewire would be passed through the needle and looped in the gallbladder. The Hot AXIOS stent would then be inserted. A naso-gallbladder drain or a 5-7Fr double pigtail stents can be inserted into gallbladder if the effluent failed to clear after irrigation. This would be performed to improve drainage and avoid obstruction of the stent. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall morbidities | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent. | 30 days |
| Pain scores | Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong | Hong Kong | Hong Kong | China | |||
| Kinki University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23206813 | Background | de la Serna-Higuera C, Perez-Miranda M, Gil-Simon P, Ruiz-Zorrilla R, Diez-Redondo P, Alcaide N, Sancho-del Val L, Nunez-Rodriguez H. EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent. Gastrointest Endosc. 2013 Feb;77(2):303-8. doi: 10.1016/j.gie.2012.09.021. Epub 2012 Dec 1. No abstract available. | |
| 22301347 |
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| OTHER |
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|
| Percutaneous cholecystostomy (PC) | Procedure | Trained interventional radiologists in the respective hospitals would perform the procedure under local anesthesia. A transhepatic route would be used in all patients to decrease bile leakage. An 8.5 Fr pigtail drainage catheter would be placed between the 8th or 9th intercostal space under sonographic and fluoroscopic guidance. The pigtail catheter would be drained to a bedside bag. |
|
| 7 days |
| Analgesic requirements | The amount of analgesic consumed during admission will be recorded and compared between groups. Oral panadol and intravenous tramadol (or equivalent) would be provided as required to patients. | 7 days |
| Stone clearance rates | The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography | 1 years |
| Clinical success | Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts. | 30 days |
| Reintervention rate | The number of patients requiring biliary related re-interventions within 1 year | 1 year |
| Re-admission rate | The number of patients requiring hospital re-admissions due to biliary related events | 1 year |
| Osaka |
| Japan |
| Tokyo Medical University Hospital | Tokyo | Japan |
| University Hospital Rio Hortega | Barcelona | Spain |
| Itoi T, Binmoeller KF, Shah J, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc. 2012 Apr;75(4):870-6. doi: 10.1016/j.gie.2011.10.020. Epub 2012 Jan 31. |
| 24830582 | Background | Teoh AY, Binmoeller KF, Lau JY. Single-step EUS-guided puncture and delivery of a lumen-apposing stent for gallbladder drainage using a novel cautery-tipped stent delivery system. Gastrointest Endosc. 2014 Dec;80(6):1171. doi: 10.1016/j.gie.2014.03.038. Epub 2014 May 13. No abstract available. |
| 32165407 | Derived | Teoh AYB, Kitano M, Itoi T, Perez-Miranda M, Ogura T, Chan SM, Serna-Higuera C, Omoto S, Torres-Yuste R, Tsuichiya T, Wong KT, Leung CH, Chiu PWY, Ng EKW, Lau JYW. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020 Jun;69(6):1085-1091. doi: 10.1136/gutjnl-2019-319996. Epub 2020 Mar 12. |