跳至主要内容
临床试验/NCT04780256
NCT04780256招募中不适用

Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract

Azienda USL Reggio Emilia - IRCCS1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年3月15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
入组人数
2,000
试验地点
1
主要终点
recurrence rate

研究概览

简要总结

The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • all patients who have undergone endoscopic resection of an upper or lower digestive tract tumor

排除标准

  • age under 18
  • inability to provide informed consent

结局指标

主要结局

recurrence rate

时间窗: one year

recurrence is the recurrence of the neoplasm at the resection site during follow-up

complete resection rate

时间窗: one month

the complete resection is the ability to remove the neoplasia with clear margins (R0)

en bloc resection rate

时间窗: one month

the en bloc resection is the ability to remove the neoplasia in a single piece

次要结局

  • adverse events rate(one month)
  • costs(one month)

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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