跳至主要内容
临床试验/NCT05468008
NCT05468008招募中不适用

Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in Western Population

AdventHealth1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
AdventHealth
入组人数
1,000
试验地点
1
主要终点
Evaluate the utility of ESD for treatment of gastrointestinal lesions

研究概览

简要总结

This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic submucosal dissection. All patients will receive standard of medical care and no experimental interventions will be performed.

详细描述

The technique of Endoscopic Mucosal Resection (EMR) is currently widely used in the US to remove precancerous or cancerous lesions confined to the mucosa of the GI tract. EMR carries lower morbidity and mortality compare to surgery, at the expense of a higher rate of piecemeal removal, incomplete resection and cancer recurrence. Endoscopic Submucosal Dissection (ESD) is a newer technique developed in Japan that involves en-bloc resection of the entire lesion irrespective of size, allowing for a detailed analysis of the resected margins and depth of invasion and producing a lower local recurrence. Due to the lack of dedicated ESD devices the procedure has not been disseminated in Western countries. Recently the Food and Drug Administration (FDA) approved a number of devices for ESD. The vast majority of studies evaluating the clinical outcomes from ESD are originating in Japan where the technique is mostly applied to patients with early gastric cancer (Japan has the highest incidence of gastric cancer in the word). In the US lesions that are currently treated with EMR are mostly located in the esophagus (Barrett esophagus) and colon (large adenomatous polyps and intramucosal cancer). These esophageal and colonic lesions can be treated with ESD with expected higher rate of en-block resection and lower recurrence rate compare to EMR. With the differences in patient population and disease location one can anticipate some differences in outcomes between ESD performed in Asian and US patients. Therefore, the investigator wants to prospectively record the experience with ESD done as part of routine medical care in United States (US) population. This will be a prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Age 18 years or older
  • Scheduled to undergo ESD

排除标准

  • Any contraindication to performing endoscopy
  • Participation in another research protocol that could interfere or influence the outcomes measures of the present study.

结局指标

主要结局

Evaluate the utility of ESD for treatment of gastrointestinal lesions

时间窗: 12 months

The primary endpoint of this study will be the prospective evaluation of the utility of ESD for the endoscopic treatment of GI lesions.

次要结局

  • En-Bloc Resection Rate(6 months)
  • Complete Resection Rate(6 months)
  • Curative Resection Rate(6 months)
  • Safety- Adverse Events(12 months)

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (1)

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