Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Subcentimetric Colorectal Polyps: the E-scope (Efficacy and Safety of COld PolypEctomy) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Percentage of complete polyp removal
研究概览
简要总结
Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality.
Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel perforation, so that a careful balance between efficacy and safety appears to be clinically relevant.
Most of the polypectomies are performed for diminutive (<5 mm) or small (6-9 mm) lesions, which represent over 90% of all the polyps.
To minimize the risk of complications when removing <10 mm polyps, cold-polypectomy techniques - i.e. without electric current - by means of biopsy forceps or snare, have been proposed.
Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of electrocautery may result in an increased risk of bleeding. The safety of cold-snare polypectomy has however been recently shown in controlled trials.
Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual disease), and no studies have compared it to conventional polypectomy.
The investigators perform this study to assess both the efficacy and safety of a novel snare (Exacto™) for polyp removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •All consecutive patients undergoing colonoscopy, with at least one and no more than 5 polyps <10 mm.
- •The patient is at satisfactory risk to undergo abdominal surgery.
- •The patient must understand and provide written consent for the procedure.
排除标准
- •Patients with inflammatory bowel disease.
- •Patients undergoing standard snare resection (with cautery) of polyps larger than 10 mm.
- •Patients with a personal history of polyposis syndrome.
- •Patients with suspected chronic stricture potentially precluding complete colonoscopy.
- •Patients with diverticulitis or toxic megacolon.
- •Patients with a history of radiation therapy to abdomen or pelvis.
- •Patients with a history of severe cardiovascular, pulmonary, liver or renal disease.
- •Personal history of coagulation disorders or use of anticoagulants/clopidogrel/aspirin/ticlopidine.
- •Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
研究组 & 干预措施
Colonic polyps
Exacto™
干预措施: Exacto™ (Device)
结局指标
主要结局
Percentage of complete polyp removal
时间窗: One year
Clinical success, defined as absence of polyp tissue, either hyperplastic or adenomatous, on the margins of the polypectomy area after cold-polypectomy of subcentimetric polyps. Such assessment is performed on two biopsies performed on the polypectomy scar. The investigators will calculate the percentage (%) of complete and incomplete polypectomies with the new device.
次要结局
- Clinical success according to size(One year)
- Post-polypectomy bleeding rates(One year)
研究者
Michele Tedeschi
Responsible of the Clinical Research Project
Istituto Clinico Humanitas