Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy
NCT ID: NCT04167072
Last Updated: 2020-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-11-01
2021-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Scheduled removal
This group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder
Stent removal
This is a procedural intervention in which the stent will be removed via endoscopy.
Observation
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.
Stent removal
This is a procedural intervention in which the stent will be removed via endoscopy.
Interventions
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Stent removal
This is a procedural intervention in which the stent will be removed via endoscopy.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
100 Years
ALL
No
Sponsors
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Texas Tech University Health Sciences Center, El Paso
OTHER
Responsible Party
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Antonio Mendoza-Ladd
Assistant Professor of Medicine/Director of Endoscopy
Locations
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University Medical Center of El Paso
El Paso, Texas, United States
Countries
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Other Identifiers
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E20025
Identifier Type: -
Identifier Source: org_study_id
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