Clinical trial NCT05893511: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Cholecystitis
Keywords: acute cholecystitis
EUS-guided gallbladder drainage
antibiotics
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 1-year recurrent acute cholecystitis rate
timeFrame: 1-year
Secondary outcomes:
measure: Technical success
timeFrame: 1-year
measure: Daily post-procedural pain scores for the first 7 days
timeFrame: 7 days
measure: Type and dosage of analgesic required
timeFrame: an average of 7 days
measure: Adverse events
timeFrame: 1-year
measure: Total number of unplanned readmissions related to acute cholecystitis and reinterventions
timeFrame: 1-year
measure: Cost-effectiveness measurement
timeFrame: 1-year
measure: Quality of life assessment
timeFrame: 1-year
measure: Clinical success
timeFrame: 1-year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese Universtiy of Hong Kong
Study officials:
affiliation: The Chinese Universtiy of Hong Kong
name: Shannon Melissa Chan
role: PRINCIPAL_INVESTIGATOR
References: