Impact of EUS Guided Treatment of Gastric Varices

NCT ID: NCT05521685

Last Updated: 2024-01-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-19

Study Completion Date

2023-05-22

Brief Summary

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The purpose of the study is to determine the clinical impact of cyanoacrylate tissue adhesive treatment for Gastric Varices performed by Indiana University EUS physicians.

Detailed Description

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Using an IRB approved database (IU IRB#1209009522; NCT02037659), data collected from the database will be evaluated to identify complications, risk of rebleeding, death within 1 year of treatment, varices eradication and need for re-intervention associated with cyanoacrylate tissue adhesive (Dermabond) treatment performed by Indiana University Endoscopic Ultrasound (EUS) physicians.

Conditions

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Gastric Varices Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Endoscopic Ultrasound (EUS) administration of cyanoacrylate tissue adhesive to control bleeding gastric varices

Subjects will have undergone treatment and been enrolled into the existing registry.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Any subject enrolled into the existing database (IU IRB#1209009522; NCT02037659).

Exclusion Criteria

* Not enrolled into the database.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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John DeWitt

Professor of Medicine and Director of Endoscopic Ultrasound

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John M. DeWitt, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine and Director of Endoscopic Ultrasound

Locations

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Indiana University

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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14954

Identifier Type: -

Identifier Source: org_study_id

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