Dermabond Treatment for Gastric Variceal Bleeding

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.

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Key information

Conditions

Gastric Varices Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202-5121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Anyone receiving treatment with DermaBond for treatment gastric varices.

Exclusion criteria

No evidence of gastric varices.

Treatment and study plan

DermaBond treatment of Gastric Varices

Procedure

Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices.

Other names: DermaBond: (cyanoacrylate tissue adhesive).

Primary outcomes

To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Endoscopic Ultrasound (EUS) Gastric Variceal Bleeding Database Repository

Important dates

Study start: 2012
Primary completion: 2022
Study completion: 2022
First posted: Jan 16, 2014
Registry last updated: Mar 29, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed