EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy
Acute Cholecystitis
About this trial
This is an interventional treatment trial for Acute Cholecystitis focused on measuring acute cholecystitis, EUS-guided gallbladder drainage, antibiotics
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
Sites / Locations
- The Chinese Universtiy of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Antibiotics first group
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD)
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.