Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps- A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Incomplete resection rate of diminutive polyps
研究概览
简要总结
Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective technique for removal of diminutive polyps. Both thick and thin wire snares are now commonly used for CSP. However, because of their physical characteristics, thick wire snares might leave a higher percentage of residual adenoma at the resection site. Since this may result in a higher risk of recurrence, the technique needs to be optimized. Experts have suggested that a thin wire snare might be more efficient, with a lower risk of residual adenoma at the resection site and consequently a lower risk of recurrence and interval cancer.
详细描述
Approximately 90% of polyps are smaller than 10 mm. Given the risk of transformation of adenomas into invasive cancer over years, it is important that these adenomas are completely resected.
This will be a double-blind, prospective, randomized controlled trial. All eligible patients referred for a colonoscopy will be able to participate. There will be 2 treatment arms, one arm will be treated with a thin wire snare and the other with a thick wire snare. Patients will be randomised through a computer generated programme and blinded for the type of snare used. The treatment arm will be disclosed to the proceduralist after introduction of the colonoscope into the rectum. After resection of the polyp the defect will be carefully examined by the proceduralist. In case of suspicion of residual adenomatous tissue, a re-excision will be performed. If there's a protrusion noticeable at the resection site, this will be biopsied. Ultimately, the margins of the defect will be biopsied on either side for histological confirmation of complete removal.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
- •Patients referred to Auburn Hospital Endoscopy Unit for a colonoscopy for whatever reason
- •At least 1 lesion <10mm beyond the rectosigmoid junction without any endoscopic features of malignancy
- •At least 1 lesion <10mm beyond the rectosigmoid junction that according to the proceduralist, can be safely removed with CSP
排除标准
- •Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted
- •Known coagulopathy
- •Pregnancy
- •If any doubt about the benign character of the polyp, the patient will be excluded from the study
研究组 & 干预措施
Thin Wire Snare Arm
Use of Thin Wire Snare to resect polyp <10mm
干预措施: Thin Wire Snare (Device)
Thick Wire Snare Arm
Use of Thick Wire Snare to resect polyp <10mm
干预措施: Thick Wire Snare (Device)
结局指标
主要结局
Incomplete resection rate of diminutive polyps
时间窗: 1 year
biopsies of the margin are analysed histologically and if any adenoma is found on biopsy, this means the resection with the cold snare was incomplete
Percentage of protrusions
时间窗: 1 year
cold snare polypectomy can leave a protrusion in the defect, which has previously been shown to be bunched up submucosa. We will record after every polypectomy if a protrusion was visible and if it depends on the snare whether a protrusion occurs or not
次要结局
- Post polypectomy bleeding requiring intervention(1 year)
- Measurement of the need for second excision in case of endoscopically visual residual adenoma(1 year)
研究者
Eric Lee
Staff Specialist Gastroenterology
Western Sydney Local Health District