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Clinical Trials/NCT02037659
NCT02037659
Completed
Not Applicable

Endoscopic Ultrasound (EUS) Gastric Variceal Bleeding Database Repository

Indiana University1 site in 1 country98 target enrollmentDecember 2012
ConditionsGastric Varices

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Varices
Sponsor
Indiana University
Enrollment
98
Locations
1
Primary Endpoint
To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
March 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John DeWitt

Director, Endoscopic Ulatrsound

Indiana University

Eligibility Criteria

Inclusion Criteria

  • Anyone receiving treatment with DermaBond for treatment gastric varices.

Exclusion Criteria

  • No evidence of gastric varices.

Outcomes

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.

Study Sites (1)

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