Efficacy and Safety Research of Cold Snare Polypectomy and Hot Snare Polypectomy in the Treatment of 4-9 mm Diameter Colorectal 0-Isp and 0-Ip Polyps: a Prospective, Multicenter, Randomized Controlled Study(FAST -REST Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 982
- 试验地点
- 1
- 主要终点
- Complete resection rate
研究概览
简要总结
This study will evaluate the efficacy and safety of cold snare polypectomy(CSP) and hot snare polypectomy(HSP) in the treatment of colorectal 4-9mm 0-Isp and 0-Ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and the number of metal clips used. The conclusion of this study will help clinical doctor develop more effective resection strategies for colorectal 0-Isp and 0-Ip polyps, and provide more effective treatment for patients.
详细描述
Colorectal polyps are one of the precancerous lesions of colorectal cancer, 60-80% of which eventually become advanced colorectal cancer. Therefore, early resection of colorectal polyps can effectively reduce the incidence of colorectal cancer. Polyps under white light are judged mainly according to the shape, size and color of polyps. At present, the Paris classification is often used to divide 0-I uplifted polyps into sessile polyps (0-Is), sessile-pedunculated polyps (0-Isp) and pedunculated polyps (0-Ip). It is generally believed that there are thick arteries in 0-Ip polyps, especially thick pedunculated polyps, which are prone to uncontrollable bleeding during operation. 0-Is polyps have small scattered blood vessels and low intraoperative bleeding risk, while the morphological and structural characteristics of 0-Isp polyps are between the two. The current guidelines recommend HSP for 0-Isp and 0-Ip polyps <1 cm, but the internal blood vessels of these polyps are not thick. There is no guidance on whether they can be resected by CSP method, and there is a lack of prospective large sample clinical research. This study will include0-Isp /0-Ip polyps <1cm, and observe the safety and effectiveness of CSP for the above polyp resection , so as to provide reference for the clinical treatment of 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old, male or female
- •At least one polyp with size of 4-9 mm 0-Isp or 0-Ip is found during colonoscopy
- •Voluntarily sign informed consent for endoscopic treatment
排除标准
- •Boston Bowel Preparation Scale<6 points.
- •Patients who receive antiplatelet/anticoagulant therapy within 5 days before polypectomy.
- •Participants with a contraindication to colonoscopy and polypectomy.
- •Patients with inflammatory bowel disease or gastrointestinal polyposis.
- •Lesions with submucosal invasion and those suspected of being cancerous at the preprocedural diagnostic evaluation.
- •Patients with pregnancy.
结局指标
主要结局
Complete resection rate
时间窗: Up to 5-7 days from operation day
The polyps and the two biopsies from the margin will be sent to the pathologist for further analysis. Two independent experienced pathologists will evaluate the samples separately and both are blinded to the technique performed for polypectomy. Complete resection rate is defined as the negative pathological evaluation of two biopsies obtained from the margin.
次要结局
- Operation time(From the snare/ injection needle exits the working channel to leaving the wound.)
- Postoperative delayed bleeding rate(Up to 14 days from operation day)
- Intraoperative bleeding rate(Up to 1 minute from the time the polyp is resected)
- En bloc resection rate(Up to 7 days when the pathologists finish the evaluations.)
- Other related postoperative complications(Up to 48 Hours from the time the polyp is resected)
- Number of metal clips used(The time when the operation is completed)
研究者
ZOU DUOWU
Director of Gastroenterology Department
Ruijin Hospital