Cap Endoscopic Mucosal Resection(EMR-C) Versus Endoscopic Submucosal Dissection(ESD) for Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- complete resection rate(R0 rate)
研究概览
简要总结
Cap-assisted endoscopic mucosal resection (EMR-C) and endoscopic submucosal dissection (ESD) have both been reported to be effective treatment methods for small rectal neuroendocrine tumor (NET) in limited studies. Which one is better has not been determined. We aimed to compare the efficacy and safety of EMR-C and ESD for the treatment of small rectal NET.
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;
- •Definite diagnosis of rectal NET less than 10mm;
- •Patients plan to receive either EMR-C or ESD treatment.
排除标准
- •Serious comorbid diseases such as advanced malignant tumor and organ failure;
- •Patients received conventional EMR, snare electrotomy and no treatment;
- •Rectal NET with metastasis;
- •Pregnant patient;
- •Poor compliance
研究组 & 干预措施
ESD group
In ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET
干预措施: ESD procedure (Procedure)
EMR-C group
In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET
干预措施: EMR-C procedure (Procedure)
结局指标
主要结局
complete resection rate(R0 rate)
时间窗: within 14 days after procedure
Complete resection was defined as negative horizontal and vertical margins of specimen.
次要结局
- operating time(intraoperative)
- hospitalization cost(within 14 days after procedure)
- complications rate(within 14 days after procedure)
- length of stay(within 14 days after procedure)
- recurrence rate(one year after procedure)