Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas (>20 mm): the "CO.W.L." Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 330
- 主要终点
- Success rate of resection defined as absence of residual/recurrence in SC1 and/or SC2
研究概览
简要总结
This randomized, multi-center trial aims to evaluate the advantages of underwater cold endoscopic mucosal resection technique (CS-EMR) in comparison to the conventional endoscopic mucosal resection technique (EMR) for laterally spreading colorectal lesions exceeding 20 mm in size. More precisely, our hypothesis posits that underwater cold EMR is non-inferior to conventional EMR in terms of recurrence rates, resection completeness and safety.
详细描述
Endoscopic mucosal resection stands as one of the most commonly employed techniques for the removal of gastrointestinal lesions, particularly within the colon. "Piece-meal" endoscopic mucosal resection is the preferred approach for large colonic polyps without signs of deep infiltration. This method consists of the removal of lesions in multiple fragments.
The conventional procedure starts with the initial submucosal infiltration of the submucosal layer using a physiological solution and methylene blue, forming a cushion that facilitates tissue transection with the assistance of a diathermic snare. The goal is to remove the lesions in larger fragments whenever possible.
In contrast, the "cold" procedure, employs a specialized snare that enables tissue transection without the need for electrical current. This approach yields the same outcome as the conventional procedure but offers the advantage of reducing the risks associated with the use of diathermic current. Subsequently, the lesion fragments are retrieved for histological examination.
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
- 是
入选标准
- •all patients ≥ 18 years of age undergoing colonoscopy for any indication (screening, anaemia, surveillance)
- •patients who were able to give informed written consent.
排除标准
- •lesions suspicious for submucosal invasion (e.g. Kudo V or Paris 0-IIa-IIc with nongranular surface).
- •lesions with large (>10 mm) Paris 0-Is component that could compromise the nodular en-bloc resection and increase risk of submucosal invasion.
- •suspected sessile serrated adenomas (SSAs) according to traditional features such as adherent surface mucus, cloud-like surface, interruption of mucosal vessels, Kudo II-o pit pattern.
- •pedunculated polyps
- •active/quiescent colitis
- •patients with other lesions resected by hot snare during the same procedure.
- •rectal lesions
- •residual or recurrent adenoma after endoscopic mucosal resection
结局指标
主要结局
Success rate of resection defined as absence of residual/recurrence in SC1 and/or SC2
时间窗: at 6 and/or 12 months
次要结局
- Rate of delayed bleeding of the patient(2 years)
- technical success(2 years)
- Rate of delayed perforation(2 years)
- Rate of post-polipectomy syndrome(2 years)
- Rate of intraprocedural adverse events such as bleeding or perforation(2 years)
- Avarage time of procedure and polyp resection time(2 years)