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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Kinki University Hospital
Osaka, Japan
Tokyo Medical University Hospital
Tokyo, Japan
University Hospital Rio Hortega
Barcelona, Spain
Overall morbidities
Time frame: 1 years
Technical success
Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.
Time frame: 30 days
Pain scores
Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
Time frame: 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.
Time frame: 7 days
Stone clearance rates
The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography
Time frame: 1 years
Clinical success
Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.
Time frame: 30 days
Reintervention rate
The number of patients requiring biliary related re-interventions within 1 year
Time frame: 1 year
Re-admission rate
The number of patients requiring hospital re-admissions due to biliary related events
Time frame: 1 year
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