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

Launched by CHINESE UNIVERSITY OF HONG KONG · May 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different approaches for treating acute cholecystitis, which is inflammation of the gallbladder. This condition often affects older patients who are not good candidates for surgery due to their health. The trial compares two treatments: one group will receive endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), which is a procedure to drain the gallbladder without major surgery, while the other group will be treated with antibiotics first. The main goal is to see if EUS-GBD can help reduce the chances of having recurring acute cholecystitis within a year.

To participate in this study, individuals must be 18 years or older and diagnosed with a specific type of mild to moderate acute cholecystitis. They should also be considered very high-risk for undergoing surgery, either due to their overall health or because they have chosen not to have surgery. Participants can expect to be randomly assigned to one of the two treatment groups and will be monitored for a year to evaluate how well each treatment works, any pain experienced, and overall quality of life. This research could help improve treatment options for patients who are unable to have surgery due to their health conditions.

Gender

ALL

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