Underwater Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for the Treatment of Small Rectal Neuroendocrine Tumors: A Prospective, Multicenter, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- histological complete resection
研究概览
简要总结
Underwater endoscopic mucosal resection (UEMR) and endoscopic submucosal dissection (ESD) have both been reported to be two effective treatment methods for small rectal neuroendocrine tumor (NET). However, there is no consensus on the best method for the endoscopic resection of rectal NET. Therefore, we aimed to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET.
详细描述
Researchers plan to conduct a prospective, multicenter, non-inferiority, randomized controlled trial to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET in ten endoscopic centers 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, CT scan or colonoscopy;
- •With tumor size ≤10 mm assessed by colonoscopy or EUS;
- •Plan to receive UEMR or ESD treatment and provide written informed consent.
排除标准
- •Unable to tolerate ESD or UEMR as assessed by the research team;
- •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
UEMR group
In UEMR group, enrolled patients will receive UEMR to remove small rectal NET.
干预措施: UEMR procedure (Procedure)
ESD group
In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove small 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
- length of stay(within 14 days after procedure)
- success rate of operation(intraoperative)
- en bloc resection(intraoperative)
- operation time(intraoperative)
- complications(within 14 days after procedure)
- operation cost(within 14 days after procedure)
- hospitalization cost(within 14 days after procedure)
- histopathologic grade(within 14 days after procedure)