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临床试验/NCT05690490
NCT05690490进行中(未招募)不适用

Treament for Colorectal Neoplasms by Metod Endoscopic Mucosal Resection With Circumferential Mucosal Incision

State Scientific Centre of Coloproctology, Russian Federation1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
90
试验地点
1
主要终点
R0 resection rate

研究概览

简要总结

This is a prospective randomized trial to improve the results of treatment of patients with colorectal neoplasms.

详细描述

Generally, endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are the methods of choice for the removal of benign and early malignant neoplasms of the colon. However, there are certain difficulties in terms of the EMR technique - this is an increase in the frequency of fragmentation with a lesion size of more than 20 mm, which in turn increases the risk of recurrence; with regard to ESD technique, this is a long procedure time; high incidence of complications; significant time required for teaching the technique; technical difficulties. In this regard, it is worth paying attention to the method of "endoscopic mucosal resection with circumferential mucosal incision" (C-EMR). This method deserves interest due to the fact that it allows more often to perform en-block resections in comparison with the classical method of endoscopic mucosal resection (EMR - endoscopic mucosal resection); technically easier to do; takes a short procedure time.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with benign colon neoplasms without signs of deep invasion (I, II, IIIL and IV type according to Kudo, I and II type according to Sano)
  • the size of the neoplasm is from 20 mm to 30 mm
  • patient for treatment

排除标准

  • unsatisfactory tumor lifting
  • refusal of the patient from research at any stage of treatment

结局指标

主要结局

R0 resection rate

时间窗: 14 day

次要结局

  • intervention time(1 day)
  • conversion rate(1 day)
  • En-block resesction rate(14 day)
  • intra- and postoperative complications rate(30 day)

研究者

发起方
State Scientific Centre of Coloproctology, Russian Federation
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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