Dermabond Treatment for Gastric Variceal Bleeding

Gastric Varices Clinical Trial

Official title:

Endoscopic Ultrasound (EUS) Gastric Variceal Bleeding Database Repository

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037659
• Other study ID #: Dermabond
• Status: Completed
• Start date: December 2012
• Est. completion date: March 2022

Study information

• Verified date: March 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Anyone receiving treatment with DermaBond for treatment gastric varices.

Exclusion Criteria:

No evidence of gastric varices.

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Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric Varices

Intervention

Procedure:
• DermaBond treatment of Gastric Varices
Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices.

Locations

Country	Name	City	State
United States	Indiana University Hospital	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	To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding.	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.	36 months