Objectives Acute cholecystitis commonly occurs in elderly patients who are at high-risk for surgery. Whether upfront Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is advantageous over antibiotics first for mild acute cholecystitis is uncertain. Hypothesis to be tested The aim is to compare EUS-GBD versus standard protocol (antibiotics first) as a definitive treatment, in very high-risk patients suffering from mild to moderate acute cholecystitis. We hypothesize that EUS-GBD can reduce the 1-year risk of recurrent acute cholecystitis. Design and subjects This is an international randomised controlled study including consecutive patients suffering from acute cholecystitis that are very high-risk for cholecystectomy. The patients would be randomized to receive EUS-GBD or antibiotics first. Interventions: EUS-GBD versus antibiotics Main outcome measures: The primary outcome is the rate of recurrent acute cholecystitis in 1 year. Other outcomes include technical and clinical success, post-procedural pain scores, analgesic requirements, adverse events, re-admissions, re-interventions, quality of life and cost analysis. Data analysis All outcomes would be analysed according to the intention-to-treat principle. Kaplan-Meier method with the log-rank test will be used to compare differences in recurrent acute cholecystitis in 1 year. A health economic analysis will also be performed. Assuming a 17.1% difference in recurrent acute cholecystitis rates, a 2-sided P value of 0.05, a power of 80%, and a 10% dropout rate, 110 patients is required. Expected results The findings of this study can help establish the role of EUS-GBD in management of high-risk patients suffering from acute cholecystitis over antibiotics alone and Percutaneous transhepatic gallbladder drainage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Prior to the procedure, the patients would be kept fasted for 6 hours and antibiotics would be commenced (2nd generation cephalosporin or equivalent). EUS-GBD would be performed by either the conventional or direct method. A 10mm stent system would be used if the largest gallstone is smaller than 10mm in size and a 16mm stent is used if the largest gallstone is larger than 10mm. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder is completely emptied by suction and irrigation until the effluent through the stent is clean. The need of inserting an additional double pigtail plastic stent through the LAMS would be decided by the endosonographer. A course of antibiotics will be continued for 7 days after the procedure .
Patients randomized to antibiotics first would be given intravenous antibiotics 2nd generation cephalosporin or equivalent). Antibiotics would first be given parenterally and then switched to oral form when patient can tolerate diet or when sepsis subside. It will be continued for at least a total of 7 days.
The Chinese Universtiy of Hong Kong
Hong Kong, Hong Kong
RECRUITING1-year recurrent acute cholecystitis rate
recurrent acute cholecystitis rate in 1 year
Time frame: 1-year
Technical success
Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or maintenance of good drainage.
Time frame: 1-year
Daily post-procedural pain scores for the first 7 days
Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
Time frame: 7 days
Type and dosage of analgesic required
Type and the dosage of the analgesic required after procedure/administered of antibiotics would be recorded.
Time frame: an average of 7 days
Adverse events
Any adverse events occured in 1 year will be recorded
Time frame: 1-year
Total number of unplanned readmissions related to acute cholecystitis and reinterventions
The total number and the reason of any unplanned readmissions related to acute cholecystitis and reinterventions in 1 year will be recorded.
Time frame: 1-year
Cost-effectiveness measurement
1. All costs in the antibiotics first arm would be recorded: the cost of using antibiotics (dose, frequency, duration), the cost of Percutaneous Transhepatic Gallbladder Drainage (PT-GBD) and subsequent cholecystogram if any 2. All costs in the EUS-GBD arm would be recorded: the cost of EUS-GBD procedure (including the procedure itself, anaesthesia, Lumen-apposing metal stents (LAMS), needle, guidewire), cost of managing complications if any 3. All costs in both arms would be recorded: i. Index admission: the cost of investigations (blood test, imaging), medications, hospital stay ii. Unplanned readmissions: the cost of investigations, medications, reinterventions (cost of procedure and its equipment) iii. Cost of the follow-up clinic visits
Time frame: 1-year
Quality of life assessment
EQ-5D on admission (before randomisation) and at every follow-up clinic visit
Time frame: 1-year
Clinical success (clinical symptoms)
Clinical success is defined as afebrile on post-treatment day 3, or temperature downward trend; and resolution of peritoneal signs.
Time frame: 1-year
Clinical success (laboratory tests)
Clinical success is defined as leucocytes count of \>=30% drop on post-treatment Day 3 or normalised.
Time frame: 1-year
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