Cold SNAre Versus Cold forcePS Polypectomy for Small Colorectal Lesions (Cold-SNAPS): a Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Incomplete resection rate
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and the safety of a new device for cold forceps polypectomy (CFP)- a special jumbo forceps- to cold snare polypectomy (CSP) for small colorectal lesions, without adding peri- or post-procedural risks to the patient.
The main questions it aims to answer are:
- Does the cold forceps guarantee a complete endoscopic resection rate?
- How many adverse events could the jumbo forceps reduce in comparison to CSP?
- Does the lesion retrieval rate increase?
- Does the polypectomy duration decrease? Participants will be randomized to one or to the other group when a polypoid or non-polypoid lesion is identified. If multiple polyps are found in the same patient, they will be removed using the same polypectomy technique.
If polypectomy cannot be performed using the indicated technique, a crossover will be done according to the best practice of care principles.
详细描述
The study is a Multicenter, Prospective, Randomized, Controlled Study. It is designed as a non-inferiority trial to assess whether the efficacy in polypectomy of the new jumbo cold forceps is non-inferior to that of the cold snare.
The investigators hypothesize a less number of adverse events with CFP, an increased lesion retrieval rate and a less duration of the polypectomy procedure.
All patients will be contacted, 30 days post-polypectomy, by blinded medical staff assessing for possible complications.
All consecutive patients with polyp lesions can be enrolled, the participation is voluntary and randomization will be performed using the "minimization technique".
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
盲法说明
Only the medical staff who will assess for possible complications, by calling patients 30 days post-polypectomy, will be blinded.
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 aged ≥ 18 years;
- •Ability to provide informed consent;
- •Presence of at least one colorectal polypoid/non-polypoid lesion < 10 mm
排除标准
- •Primary or secondary coagulopathy;
- •Improper interruption of dual antiplatelet therapy and/or antiplatelet therapy with P2Y12 receptor antagonists (clopidogrel, prasugrel, ticagrelor) and/or anticoagulant therapy;
- •Chronic inflammatory bowel diseases;
- •Inpatients undergoing colonoscopy;
- •Colonoscopy as part of regional colorectal cancer screening;
- •Pregnancy or breastfeeding
结局指标
主要结局
Incomplete resection rate
时间窗: Immediately after the procedure and immediately after the histological evaluation of the biopsy samples
Compare the rate of incomplete endoscopic resection (IER) of CFP and CSP, defined as the presence of residual adenomatous tissue in the biopsy samples of the margins or after the visual assessment of the resection base.
次要结局
- Adverse events(Up to 30 days after the procedure)
- Lesion retrieval rate(During the polypectomy)
- Polypectomy duration(During the polypectomy)
研究者
Dr. Mauro Manno
Gastroenterology and Endoscopy Unit director
Azienda USL Modena