Brief Title
Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy
Official Title
Scheduled Stent Removal vs Observation in Patients Undergoing EUS-guided Gallbladder Drainage. A Randomized Clinical Trial.
Brief Summary
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
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
Study Type
Interventional
Primary Outcome
Recurrence of GB findings
Secondary Outcome
Rate of adverse events related to LAMS
Condition
Cholecystitis, Acute
Intervention
Stent removal
Study Arms / Comparison Groups
Scheduled removal
Description: This group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
0
Start Date
November 1, 2019
Completion Date
January 31, 2021
Primary Completion Date
January 31, 2021
Eligibility Criteria
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)
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04167072
Organization ID
E20025
Responsible Party
Principal Investigator
Study Sponsor
Texas Tech University Health Sciences Center, El Paso
Study Sponsor
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Verification Date
April 2020