Study Stopped
Unexpected difficulties recruiting and following patients
Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy
Scheduled Stent Removal vs Observation in Patients Undergoing EUS-guided Gallbladder Drainage. A Randomized Clinical Trial.
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 14, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedApril 22, 2020
April 1, 2020
1.3 years
November 14, 2019
April 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Rate of adverse events related to LAMS
1 year
Study Arms (2)
Scheduled removal
EXPERIMENTALThis group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder
Observation
ACTIVE COMPARATORThis 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.
Interventions
This is a procedural intervention in which the stent will be removed via endoscopy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center of El Paso
El Paso, Texas, 79905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine/Director of Endoscopy
Study Record Dates
First Submitted
November 14, 2019
First Posted
November 18, 2019
Study Start
November 1, 2019
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
April 22, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share