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EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy

Primary Purpose

Acute Cholecystitis

Status
Recruiting
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Endoscopic ultrasound-guided gallbladder drainage
Antibiotics first
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholecystitis focused on measuring acute cholecystitis, EUS-guided gallbladder drainage, antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Consecutive patients aged ≥ 18 years old Suffering from grade 1 or 2 acute calculous cholecystitis* At very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions** or elderly patients suffering from acute cholecystitis but refused operations Exclusion Criteria: Patients with the following conditions are excluded from the study: Pregnancy Patients unwilling to undergo follow-up assessments Patients with suspected gangrene or perforation of the gallbladder Grade III acute cholecystitis33 Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal) Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum Patients with liver cirrhosis, portal hypertension and/or gastric varices Abnormal coagulation: International normalized ratio (INR) > 1.5 and/or platelets < 50.000/mm3 Previous drainage of the gallbladder Patients suffering acute cholecystitis due to malignant cystic duct obstruction Patients with life expectancy of less than 3 years

Sites / Locations

  • The Chinese Universtiy of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Antibiotics first group

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

1-year recurrent acute cholecystitis rate
recurrent acute cholecystitis rate in 1 year

Secondary Outcome Measures

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.
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.
Type and dosage of analgesic required
Type and the dosage of the analgesic required after procedure/administered of antibiotics would be recorded.
Adverse events
Any adverse events occured in 1 year will be recorded
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.
Cost-effectiveness measurement
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 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 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
Quality of life assessment
EQ-5D on admission (before randomisation) and at every follow-up clinic visit
Clinical success
Clinical success is defined as improvement in clinical symptoms and laboratory test (i.e. liver function test and complete blood count)

Full Information

First Posted
March 27, 2023
Last Updated
May 29, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05893511
Brief Title
EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy
Official Title
Upfront Endoscopic Ultrasound-guided Gallbladder Drainage (EUS-GBD) Versus Standard Protocol (Antibiotics First) for Mild to Moderate Acute Cholecystitis in Patients Who Are Very-high-risk for Cholecystectomy: A Randomized-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
acute cholecystitis, EUS-guided gallbladder drainage, antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antibiotics first group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic ultrasound-guided gallbladder drainage
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
Antibiotics first
Intervention Description
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.
Primary Outcome Measure Information:
Title
1-year recurrent acute cholecystitis rate
Description
recurrent acute cholecystitis rate in 1 year
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Technical success
Description
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
Title
Daily post-procedural pain scores for the first 7 days
Description
Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
Time Frame
7 days
Title
Type and dosage of analgesic required
Description
Type and the dosage of the analgesic required after procedure/administered of antibiotics would be recorded.
Time Frame
an average of 7 days
Title
Adverse events
Description
Any adverse events occured in 1 year will be recorded
Time Frame
1-year
Title
Total number of unplanned readmissions related to acute cholecystitis and reinterventions
Description
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
Title
Cost-effectiveness measurement
Description
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 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 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
Title
Quality of life assessment
Description
EQ-5D on admission (before randomisation) and at every follow-up clinic visit
Time Frame
1-year
Title
Clinical success
Description
Clinical success is defined as improvement in clinical symptoms and laboratory test (i.e. liver function test and complete blood count)
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consecutive patients aged ≥ 18 years old Suffering from grade 1 or 2 acute calculous cholecystitis* At very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions** or elderly patients suffering from acute cholecystitis but refused operations Exclusion Criteria: Patients with the following conditions are excluded from the study: Pregnancy Patients unwilling to undergo follow-up assessments Patients with suspected gangrene or perforation of the gallbladder Grade III acute cholecystitis33 Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal) Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum Patients with liver cirrhosis, portal hypertension and/or gastric varices Abnormal coagulation: International normalized ratio (INR) > 1.5 and/or platelets < 50.000/mm3 Previous drainage of the gallbladder Patients suffering acute cholecystitis due to malignant cystic duct obstruction Patients with life expectancy of less than 3 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Melissa Chan
Phone
35052627
Email
shannonchan@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Melissa Chan
Organizational Affiliation
The Chinese Universtiy of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese Universtiy of Hong Kong
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon M Chan, MBCHB, FRCS
Phone
35052627
Email
shannonchan@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Anthony YB Teoh, MBCHB, FRCS
Phone
35052627
Email
anthonyteoh@surgery.cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy

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