The Clinical Outcomes After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Colorectal Neoplasms - A Multicenter Registry
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
- 否
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
Louis Ho Shing Lau
Clinical Assistant Professor
Chinese University of Hong Kong
