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临床试验/NCT04191473
NCT04191473Unknown不适用

Comparison of Precutting vs Conventional Endoscopic Mucosal Resection of Intermediate-Size Colorectal Polyps

First Affiliated Hospital of Zhejiang University7 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
220
试验地点
7
主要终点
R0 rate

研究概览

简要总结

Colorectal cancer is the third most common cancer in men and the second most common cancer in women.There are about 14 million cases of colonoscopy in the United States every year. In recent years, the incidence of colorectal cancer in China has risen sharply, becoming a serious threat to people's health.For small(≤ 9mm) lesions, endoscopic biopsy forceps and cold snare polypectomy can be used to remove.For larger lesions, especially laterally spreading tumor,endoscopic mucosal resection is a classic method of treatment.With the increasing diameter of the lesion size(> 20mm),we also need to adopt endoscopic piecemeal mucosal resection or endoscopic submucosal dissection.

As IT, Hook knife, BB, and other devices appear constantly, foreign researchers recently adopted a variation of conventional EMR(CEMR), namely endoscopic mucosal resection with circumferential precutting(EMR - P).The technology is superior to conventional EMR for 10 to 20 mm polyps.Moreover, preliminary studies suggest that it has good safety and efficacy, and may be a better method for treatment of 10-20mm polyps under colonoscopy.

This clinical trial is being conducted to compare the efficacy and safety of two methods of polypectomy, CEMR and EMR-P, for 10-20mm colorectal polyps.

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

  • One polyp or lesion of 10-20mm at the most proximal of colorectal
  • Adult patients (≥18 years old)
  • Polyps other than pedicled polyps

排除标准

  • There was submucosal infiltration under endoscope
  • Residual lesions after endoscopic resection
  • Inflammatory bowel disease, familial polyps, electrolyte abnormalities, coagulation disorders, or severe organ failure
  • Pregnant or nursing
  • No informed consent has been signed
  • Patients taking NSAIDs or other anticoagulants
  • sedated colonoscopy

结局指标

主要结局

R0 rate

时间窗: 7 days

en bloc resection with a histologically confirmed negative resection margin

En bloc rate

时间窗: immediately

endoscopically assessed removal of the lesion in one piece

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (7)

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