Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Efficacy of Procedure
研究概览
简要总结
The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders).
- To assess the clinical and technical success rates of EUS-Guided interventions
- To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.
- Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.
详细描述
Our tertiary-care institution performs clinically-indicated therapeutic Endoscopic Ultrasound (TEUS) guided interventions, including biliary and pancreatic drainage, for both malignant and benign gastrointestinal indications in more than 2000 patients annually.
Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders.
TEUS procedures are less invasive approach than surgery. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.
They improve quality of life and extend survival duration.
Currently, there is limited multi-center data on therapeutic endoscopy clinical outcomes and standardized treatment algorithms in western populations. Due to continuing variations in therapeutic EUS procedures, as well as introduction of some TEUS procedure accessories; it is necessary to periodically evaluate the efficacy and safety of specific TEUS procedures and accessories for several indications to check for improved clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
排除标准
- •Subjects not undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
结局指标
主要结局
Efficacy of Procedure
时间窗: Upto 2 years
Technical and clinical success rates
Safety of procedure
时间窗: Upto 2 years
Type, frequency and intensity of adverse events
次要结局
- Cost Effectiveness(Upto 2 years)