Laparoscopic cholecystectomy (LC) represents the gold standard for treatment of elective and acute of gallbladder diseases, such as acute cholecystitis (AC). However, in elderly patients or in those with severe comorbidities, urgent LC can be associated with increase morbidity (up to 41%) and mortality (up to 19%). In these patients, placement of a percutaneous gallbladder drainage catheter (PT-GBD) or colecistostomy can be utilized to drain the gallbladder until infection is resolved, as a bridge to subsequent surgery or as definitive treatment. PT-GBD, however, is associated with major adverse events (AEs): intra-hepatic hemorrhage, pneumothorax, biliary peritonitis, bile leak from the site of drainage, AC recurrency, self-removal of the drainage by the patient e/o for spontaneous migration. Recently, to overcome PT-GBD limitations, EUS-guided gallbladder drainage (EUS-GBD) has been introduced as an alternative minimally invasive therapeutic intervention for treatment of patients with high surgical risk who present with AC. The procedure has high technical and clinical success rates and favorable safety profile, with low risk of recurrent AC. EUS-GBD, followed, when needed, by intra-cholecystic endoscopic interventions has been utilized even in relatively young patients as recently reported with successful intra-cholecystic giant stones clearance through the LAMS using previously described endoscopic lithotripsy in patients who rejected surgery and desired gallbladder preservation. A second category of patients who might benefit from EEGBT are elderly individuals with major comorbidities posing them at high surgical risk, who suffer from previous episodes of cholecystitis, recurrent colic episodes due to gallbladder stones, or with biliary acute pancreatitis due to stones migration. Based on all the above considerations, we have designed a prospective, pilot study to evaluate the safety and efficacy of elective EEGBT performed using LAMS stent with electrocautery-enhanced delivery system, followed by intra-cholecystic endoscopic interventions when needed in elderly patients with benign gallbladder diseases at high surgical risk, in whom an indication to perform cholecystectomy was indicated.
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of adverse events (AEs) after EUS-guided gallbladder treatment
Timeframe: 1 year