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

NCT ID: NCT05893511

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-26
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Cholecystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antibiotics first group

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.

Group Type: ACTIVE_COMPARATOR

Antibiotics first

Intervention Type: 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.

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD)

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic ultrasound-guided gallbladder drainage

Intervention Type: 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 .

Interventions

Endoscopic ultrasound-guided gallbladder drainage

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: PROCEDURE

Antibiotics first

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Consecutive patients aged ≥ 18 years old

2. Suffering from grade 1 or 2 acute calculous cholecystitis*

3. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CHAN SHANNON MELISSA

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shannon Melissa Chan

Role: PRINCIPAL_INVESTIGATOR

The Chinese Universtiy of Hong Kong

Locations

The Chinese Universtiy of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Shannon Melissa Chan

Role: CONTACT

shannonchan@surgery.cuhk.edu.hk

35052627

Facility Contacts

Shannon M Chan, MBCHB, FRCS

Role: primary

shannonchan@surgery.cuhk.edu.hk

35052627

Anthony YB Teoh, MBCHB, FRCS

Role: backup

anthonyteoh@surgery.cuhk.edu.hk

35052627

Other Identifiers

2022.518

Identifier Type: -

Identifier Source: org_study_id