Comparision of Safety and Efficacy Between Modified Double Snare Assisted EMR (mDS-EMR) and ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm: a Prospective Non-inferiority Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 主要终点
- complete resection
研究概览
简要总结
The aim of this study is evaluating and safety and efficacy between the modified double snare EMR and ESD. It is intended to prove that for rectal neuroendocrine tumors within 1 cm, the complete resection rate of the mDS-EMR is not inferior to that of ESD, but may with shorter operation time, lower complication rate and lower treatment cost.
详细描述
A prospective, single-center, randomized controlled non-inferiority trial was designed to compare the safety and efficacy of modified double snare EMR (mDS-EMR) with endoscopic submucosal dissection (ESD) for the resection of rectal neuroendocrine tumors. The study have 4 main research contents. 1, Whether the resection effect of mDS-EMR is not inferior to that of ESD, and the treatment effect is evaluated by the complete resection rate (R0 resection rate). 2, Whether the operation time of mDS-EMR is significantly shorter than that of ESD. 3, To compare the safety between mDS-EMR and ESD, and whether the mDS-EMR can reduce the risk of intraoperative and postoperative adverse events. 4, To compare the postoperative hospital stay, surgical costs and hospitalization costs between mDS-EMR and ESD.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Typical rectal neuroendocrine tumors by endoscopy (within 15cm from the anal verge, yellowish subepithelial elevation with a smooth surface, and dilated blood vessels in some areas).
- •The maximum diameter of the lesion is smaller than 1cm by preoperative endoscopic assessment.
- •Lesion is located within the mucosal and submucosal layer by preoperative endoscopic assessment.
- •Patients can understand and sign the informed consent.
排除标准
- •Poor coagulation function(PT>15 seconds or APTT>45 seconds or INR>2.0)
- •With severe cardiovascular or cerebrovascular diseases and cannot tolerate operation( with a history of stroke or myocardial infarction within the past month or with severe heart failure and cardiac function grade III)
- •Indication of metastasis by preoperative imaging examinations
- •With more than or equal to 2 rectal neuroendocrine tumors
- •With other complications that are not suitable for this study by multidisciplinary team assesment
- •Cases of recurrence after operation for neuroendocrine tumors
研究组 & 干预措施
ESD
The traditional ESD treatment method is adopted, which includes submucosal injection of normal saline and methylene blue suspension, cutting and dissection by mucosal incision knife, hemostasis and cliping of the wound. Traction is allowed during the operation.
干预措施: endoscopic submucosal dissection (Procedure)
mDS-EMR
Modified double snare assisted EMR was used for treatment. Put the first snare for resecting outside the endoscope body. Then put the second snare at the base through the channel to tighten the lesion. Finally, place the first snare below the second one to tighten the lesion and perform electrically-assisted removal. Then, metal clips will be used to close the wound.
干预措施: modified double snare assisted endoscopic mucosal resection (Procedure)
结局指标
主要结局
complete resection
时间窗: Day 30
Rate of complete en bloc resection with microscopically negative margins.
次要结局
- En bloc resection(Day 30)
- operation success rate(Periprocedural)
- operation time(Periprocedural)
- Postoperative hospital stay(through study completion, an average of 30 days)
- operation-related expenses(through study completion, an average of 30 days)
- Average hospitalization expenses(through study completion, an average of 30 days)