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临床试验/NCT05653960
NCT05653960尚未招募不适用

The Clinical Outcomes After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Colorectal Neoplasms - A Multicenter Registry

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,500
试验地点
1
主要终点
Curative resection rate of EMR or ESD for colorectal neoplasms

研究概览

简要总结

This study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal EMR and ESD.

详细描述

Colorectal cancer (CRC) is one of the most common causes of cancer-related death, however its morbidity and mortality can be reduced by colonoscopy screening and endoscopic removal of adenomas or early cancers.[1] Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two main endoscopic treatment options for colorectal neoplasms. Despite being a safe and convenient procedure, insufficient resection by EMR can result in a high risk of local recurrence, particularly in lesions ≥ 20 mm. Compared with EMR, ESD facilitates a higher rate of en bloc resection and a lower rate of local recurrence. A recent meta-analysis revealed that the local recurrence rate after colorectal ESD was 1% during a 2-year follow-up period. In addition, ESD can facilitate precise pathological diagnosis to assess the risk of lymph node metastasis of early CRC to judge whether salvage surgery is needed. Although the efficacy of colorectal ESD has been demonstrated, its usage is largely limited by its technical difficulty and risk of complications.

Both short- and long-term data on clinical outcomes and safety profiles for colorectal EMR and ESD are needed. Therefore, this study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal EMR and ESD.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who undergo EMR or ESD for colorectal lesions.

排除标准

  • Not applicable.

结局指标

主要结局

Curative resection rate of EMR or ESD for colorectal neoplasms

时间窗: 10 years

The short- and long-term clinical efficacy outcomes of colorectal EMR or ESD

Adverse event rate of EMR or ESD for colorectal neoplasms

时间窗: 10 years

The short- and long-term clinical safety outcomes of colorectal EMR or ESD

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

Louis Ho Shing Lau

Clinical Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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