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NCT Number: NCT05893511

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

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.

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 .

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.

Primary outcomes

  1. 1-year recurrent acute cholecystitis rate

    Time frame: 1-year

    recurrent acute cholecystitis rate in 1 year

Secondary outcomes

  1. Technical success

    Time frame: 1-year

    Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or maintenance of good drainage.

  2. Daily post-procedural pain scores for the first 7 days

    Time frame: 7 days

    Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.

  3. Type and dosage of analgesic required

    Time frame: an average of 7 days

    Type and the dosage of the analgesic required after procedure/administered of antibiotics would be recorded.

  4. Adverse events

    Time frame: 1-year

    Any adverse events occured in 1 year will be recorded

  5. Total number of unplanned readmissions related to acute cholecystitis and reinterventions

    Time frame: 1-year

    The total number and the reason of any unplanned readmissions related to acute cholecystitis and reinterventions in 1 year will be recorded.

  6. Cost-effectiveness measurement

    Time frame: 1-year

    • 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

  7. Quality of life assessment

    Time frame: 1-year

    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.

  8. Clinical success (clinical symptoms)

    Time frame: 1-year

    Clinical success is defined as afebrile on post-treatment day 3, or temperature downward trend; and resolution of peritoneal signs.

  9. Clinical success (laboratory tests)

    Time frame: 1-year

    Clinical success is defined as leucocytes count of >=30% drop on post-treatment Day 3 or normalised.

Study contacts

Contact information is provided by the study sponsor or research team.

Shannon Melissa Chan

CONTACT

[email protected]

35052627

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2023
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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