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.

Study Overview

• Status: Completed
• Conditions: Gastric Varices Bleeding
• Intervention / Treatment: Procedure: Endoscopic Ultrasound (EUS) administration of cyanoacrylate tissue adhesive to control bleeding gastric varices

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects were treated for Gastric Varices with bleeding using cyanoacrylate tissue adhesive and administered by endoscopic ultrasound.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not enrolled into the database.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: John M. DeWitt, MD, Professor of Medicine and Director of Endoscopic Ultrasound

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices; Varicose Veins
• Other Study ID Numbers: 14954

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No