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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scheduled removal | Experimental | This group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder |
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| Observation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent removal | Procedure | This is a procedural intervention in which the stent will be removed via endoscopy. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center of El Paso | El Paso | Texas | 79905 | United States |
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| D002764 | Cholecystitis |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
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| D041761 |
| Cholecystolithiasis |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |