A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis. (DRAC)
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|ClinicalTrials.gov Identifier: NCT02212717|
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : July 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Cholecystitis||Procedure: EUS-guided gallbladder drainage (EGBD) Procedure: Percutaneous cholecystostomy (PC)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||March 2019|
|Active Comparator: EUS-guided gallbladder drainage||
Procedure: EUS-guided gallbladder drainage (EGBD)
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.
|Active Comparator: Percutaneous cholecystomy||
Procedure: Percutaneous cholecystostomy (PC)
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.
- Overall morbidities [ Time Frame: 1 years ]
- Technical success [ Time Frame: 30 days ]Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.
- Pain scores [ Time Frame: 7 days ]Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
- Analgesic requirements [ Time Frame: 7 days ]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.
- Stone clearance rates [ Time Frame: 1 years ]The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography
- Clinical success [ Time Frame: 30 days ]Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.
- Reintervention rate [ Time Frame: 1 year ]The number of patients requiring biliary related re-interventions within 1 year
- Re-admission rate [ Time Frame: 1 year ]The number of patients requiring hospital re-admissions due to biliary related events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212717
|China, Hong Kong|
|Chinese University of Hong Kong|
|Hong Kong, Hong Kong, China|
|Kinki University Hospital|
|Tokyo Medical University Hospital|
|University Hospital Rio Hortega|