Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics first group | Active Comparator | Antibiotics first equals to 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. |
|
| Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) | Active Comparator | Prior to the procedure, the patients would be kept fasted for 6 hours and antibiotics would be commenced (2nd generation cephalosporin or equivalent). Antibiotics would be continued for up to one week after the procedure.EUS-GBD would be performed by either the conventional or direct method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound-guided gallbladder drainage | Procedure | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year recurrent acute cholecystitis rate | recurrent acute cholecystitis rate in 1 year | 1-year |
| 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 maintenance of good drainage. | 1-year |
| Daily post-procedural pain scores for the first 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with the following conditions are excluded from the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannon Melissa Chan | Contact | 35052627 | shannonchan@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Shannon Melissa Chan | The Chinese Universtiy of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese Universtiy of Hong Kong | Recruiting | Hong Kong | HONG KONG | 00000 | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Antibiotics first | Drug | 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. |
|
Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
| 7 days |
| Type and dosage of analgesic required | Type and the dosage of the analgesic required after procedure/administered of antibiotics would be recorded. | an average of 7 days |
| Adverse events | Any adverse events occured in 1 year will be recorded | 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. | 1-year |
| Cost-effectiveness measurement |
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 | 1-year |
| Quality of life assessment | Health Questionnaire (EQ-5D) on admission (before randomisation) and at every follow-up clinic visit. The descriptive system of EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | 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. | 1-year |
| Clinical success (laboratory tests) | Clinical success is defined as leucocytes count of >=30% drop on post-treatment Day 3 or normalised. | 1-year |