Modified Cap-assisted Endoscopic Mucosal Resection and Modified Endoscopic Mucosal Resection with a Ligation Device for Small Rectal Neuroendocrine Tumors Less Than 1 Cm: a Muticenter Randomized Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- histological complete resection
研究概览
简要总结
According to clinical practice and relevant retrospective research data, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic mucosal resection with a ligation device(ESMR-L) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) . However, there is a lack of multicenter prospective studies to evaluate the advantages and disadvantages of mEMR-C and mEMR-L. mEMR-C is the modified ESMR-L without submucosal injection.
详细描述
We aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with mEMR-L for the treatment of small rectal neuroendocrine tumors (NETs) in ten tertiary hospitals in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 80 years;
- •With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy;
- •With tumor size ≤10 mm assessed by colonoscopy;
- •Plan to receive mEMR-C or mEMR-L treatment and provide written informed consent;
排除标准
- •Unable to tolerate mEMR-L or mEMR-C as assessed by the research team of each center;
- •Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;
- •Rectal NET with lymph node metastasis or distant metastasis;
- •Received resection of rectal neuroendocrine tumor by other surgical procedures;
- •Multiple rectal neuroendocrine tumors;
- •Vulnerable groups such as pregnant women or patients with mental disorders;
- •Poor compliance, unable to cooperate with treatment.
研究组 & 干预措施
mEMR-C group
In mEMR-C group, enrolled patients will receive modified EMR-C without submucosal injection.
干预措施: mEMR-C procedure (Procedure)
mEMR-L group
In mEMR-L group, enrolled patients will receive modified ESMR-L without submucosal injection.
干预措施: mEMR-L procedure (Procedure)
结局指标
主要结局
histological complete resection
时间窗: within 14 days after procedure
complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.
次要结局
- success rate of operation(intraoperative)
- en bloc resection(intraoperative)
- operation time(intraoperative)
- complications(within 14 days after procedure)
- length of stay(within 14 days after procedure)
- hospitalization cost(within 14 days after procedure)
- operation cost(within 14 days after procedure)
- histopathologic grade(within 14 days after procedure)