Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

Study Overview
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Brief Summary
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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).

Detailed Description
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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

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

Conditions
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Cholecystitis, Acute, Cholecystitis; Gallstone

Intervention / Treatment
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* Procedure: Stent removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-100 years or age Both genders Diagnosis of acute cholecystitis by TG13 criteria. Patients who are able to give consent Patients who are deemed poor surgical candidates for cholecystectomy by the surgical/medical team. Exclusion Criteria: Unable to provide informed consent Cardiorespiratory dysfunction that precludes sedation Pregnant females Presence of ascites (distance between duodenum and GB > 1 cm) and/or coagulopathy (INR > 3, PLT <20K)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scheduled removal<br>This group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder | Procedure: Stent removal<br>* This is a procedural intervention in which the stent will be removed via endoscopy.<br>|
| Active Comparator: Observation<br>This group involves patients who will be followed closely for 1 year after all the stones have been removed from the gallbladder. These patients will keep the stent in place for 1 year and at that time the patients will be offered removal of the stent. | Procedure: Stent removal<br>* This is a procedural intervention in which the stent will be removed via endoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of GB findings | To compare the recurrence of GB findings in patients undergoing EUS guided GB drainage with a lumen-apposing metal stent(LAMS) assigned to scheduled stent removal vs those assigned to long-term observation only. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events related to LAMS | To compare the rate of LAMS related adverse events in these two groups | 1 year |