An interventional study of Stent removal in Cholecystitis, Acute and Cholecystitis; Gallstone, sponsored by Texas Tech University Health Sciences Center, El Paso. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-04-22.
Sponsored by Texas Tech University Health Sciences Center, El Paso · Not applicable, Interventional, and Treatment
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
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
Browse Cholecystitis studies →Texas Tech University Health Sciences Center, El Paso is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Exclusion Criteria:
This group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder
Procedure: Stent removal
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
This is a procedural intervention in which the stent will be removed via endoscopy.
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.
Time frame: 1 year
Rate of adverse events related to LAMS
To compare the rate of LAMS related adverse events in these two groups
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center, El Paso