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