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临床试验/NCT02037659
NCT02037659已完成不适用

Endoscopic Ultrasound (EUS) Gastric Variceal Bleeding Database Repository

Indiana University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Anyone receiving treatment with DermaBond for treatment gastric varices.

排除标准

  • No evidence of gastric varices.

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John DeWitt

Director, Endoscopic Ulatrsound

Indiana University

研究点 (1)

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