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NCT04167072 Clinical Trial

Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

Cholecystitis, Acute Clinical Trial

Official title:
Scheduled Stent Removal vs Observation in Patients Undergoing EUS-guided Gallbladder Drainage. A Randomized Clinical Trial.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04167072
Other study ID # E20025
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date January 31, 2021

Study information
Verified date April 2020
Source Texas Tech University Health Sciences Center, El Paso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 31, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Stent removal
This is a procedural intervention in which the stent will be removed via endoscopy.

Locations
Country Name City State
United States University Medical Center of El Paso El Paso Texas

Sponsors (1)
Lead Sponsor Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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