Comparing Laparoscopic Surgery and Endoscopic Ultrasound-Guided Gallbladder Drainage for Acute Cholecystitis in Patients Aged 75 and Older

What this Trial Is About

The trial investigates treatments for acute cholecystitis in patients aged 75 years and older. It compares standard surgery, laparoscopic cholecystectomy LCC, with a less invasive procedure called endoscopic ultrasound-guided gallbladder drainage EUS-GBD. This study aims to evaluate whether EUS-GBD can offer acceptable clinical outcomes for elderly patients who may face higher risks with surgery due to age and other health issues. Participants are randomly assigned to receive either LCC, which involves surgical removal of the gallbladder using laparoscopic techniques, or EUS-GBD, a procedure that drains the gallbladder internally using a metal stent guided by ultrasound and performed under sedation. The EUS-GBD group may have the stent replaced or left in place depending on their health and clinical decisions. Both groups receive standard antibiotic treatment. During the study, participants are monitored through medical records and scheduled follow-up contacts. Data collected include baseline health status, procedure details, complications, hospital stays, antibiotic duration, and recurrence of cholecystitis. The main outcomes measured are the recurrence rate of cholecystitis over 24 months and length of initial hospital stay. Safety and long-term outcomes, including mortality and hospital costs, are also assessed up to 10 years after treatment.

Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD