Impact of EUS Guided Treatment of Gastric Varices

Gastric Varices Bleeding Clinical Trial

Official title:

Impact of EUS Guided Treatment of Gastric Varices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521685
• Other study ID #: 14954
• Status: Completed
• Start date: April 19, 2022
• Est. completion date: May 22, 2023

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not enrolled into the database.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric Varices Bleeding
• Varicose Veins

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of EUS guided treatment of Gastric varices post procedure complications and adverse events	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.	Complications reviewed at time of retrospective study. EUS-guided sclerotherapy done between November 2012 and December 2021