Impact of EUS Guided Treatment of Gastric Varices

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.

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Key information

Conditions

Gastric Varices Bleeding

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Not enrolled into the database.

Treatment and study plan

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

Procedure

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

Primary outcomes

Impact of EUS guided treatment of Gastric varices post procedure complications and adverse events

Time frame: Complications reviewed at time of retrospective study. EUS-guided sclerotherapy done between November 2012 and December 2021

Retrospective data review to Determine post procedure complications and adverse events at 24h, between 2 and 7 days and between 8 and 30 days after the procedure. Additionally, tracking rebleeding after first and second EUS. Moreover, looking at eradication of GV rate on second endoscopy (considered eradicated if absent or if residual varices have no or minimal flow on doppler)eradication, and need for re-intervention following cyanoacrylate tissue adhesive treatment for Gastric Varices performed by IU EUS physicians.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Aug 30, 2022
Registry last updated: Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed