Dermabond Treatment for Gastric Variceal Bleeding

Completed

• Conditions: Gastric Varices
• Interventions: Procedure: DermaBond treatment of Gastric Varices

• Registration Number: NCT02037659
• Lead Sponsor: Indiana University

Brief Summary

The purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically, for the treatment of gastric variceal bleeding This data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.

Detailed Description

Clinical outcomes research is one of the strengths of the EUS group. As a group, the physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with gastric variceal bleeding. Gastric variceal bleeding is a severe complication of portal hypertension with significant morbidity and mortality with limited therapeutic options. Currently, there is no database in existence for endoscopic ultrasound clinical research for specific procedures. Also, there is limited data regarding the outcome of endoscopic sclerotherapy with cyanoacrylate in the United States.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Status Verified: 2022-03
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Last Update Submitted: 2022-03-27
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Anyone receiving treatment with DermaBond for treatment gastric varices.

Exclusion Criteria

No evidence of gastric varices.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastric Varices treatment	DermaBond treatment of Gastric Varices	DermaBond (glue) treatment of Gastric Varices.

Primary Outcome Measures

Name	Time	Method
To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding.	36 months	Patients with gastric variceal bleeding will be treated with DermaBond injection via EUS (endoscopic ultrasound). A follow-up EUS will observe the treated varices and determine if retreatment with DermaBond is necessary, or if observation alone is required.

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States