Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

Scheduled Stent Removal vs Observation in Patients Undergoing EUS-guided Gallbladder Drainage. A Randomized Clinical Trial.

The study will compare the outcomes of patients with gallstone related cholecystitis who are poor surgical candidates undergoing EUS guided cholecystoenterostomy via a lumen apposing metal stent (LAMS).

The study will include patients with stone related cholecystitis that are not adequate surgical candidates that will be treated with EUS guided cholecystoenterostomy with endoscopic stone extraction. Patients will be randomized to stent removal immediately after gallstones have been removed or to observation for 1 year with the stent in place. Outcomes to be measured include recurrence of stone disease and rate of complications from the procedure in both groups

Inclusion Criteria:

1. Ages 18-100 years or age
2. Both genders
3. Diagnosis of acute cholecystitis by TG13 criteria.
4. Patients who are able to give consent
5. Patients who are deemed poor surgical candidates for cholecystectomy by the surgical/medical team.

Exclusion Criteria:

1. Unable to provide informed consent
2. Cardiorespiratory dysfunction that precludes sedation
3. Pregnant females
4. Presence of ascites (distance between duodenum and GB > 1 cm) and/or coagulopathy (INR > 3, PLT <20K)