Modified Cap-assisted Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection 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
- 102
- 主要终点
- histological complete resection
研究概览
简要总结
In previous single center study, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) and mEMR-C was inferior to ESD for the treatment of small rectal NETs (≤10 mm), as it has shorter operation times and lower hospitalization costs. However, a multicenter randomized controlled trial is needed to prove the universality and generality of these findings.
详细描述
Investigators aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with ESD for the treatment of small rectal neuroendocrine tumors (NETs) in six 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 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 ESD treatment and provide written informed consent;
排除标准
- •Unable to tolerate ESD 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)
ESD group
In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove the rectal NET
干预措施: ESD 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
- hospitalization cost(within 14 days after procedure)
- en bloc resection(intraoperative)
- success rate of operation(intraoperative)
- complications(within 14 days after procedure)
- operation time(intraoperative)
- histopathologic grade(within 14 days after procedure)
- length of stay(within 14 days after procedure)
- operation cost(within 14 days after procedure)