NCT06435377尚未招募不适用
Prospective Observational Study APC AND BIOPSY POST COLD-EMR IN COLONIC LESIONS
Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Residual
研究概览
简要总结
This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
- •Lesions of 20 mm and larger.
- •All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
- •Patients who were able to provide written informed consent
排除标准
- •Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
- •Lesions with a wide Paris 0-Is component (>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
- •Pedunculated polyps
- •Active/quiescent colitis
- •Rectal lesions
- •Residual or recurrent adenoma after endoscopic mucosal resection
结局指标
主要结局
Residual
时间窗: 1 day
Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample.
Recurrence
时间窗: 1 year
The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months.
次要结局
- perforation(1 day)
- Efficacy of procedure(1 day)
- Rate of delayed bleeding of the patient(1 day)
- Time(1 day)
- Rate of post-polipectomy syndrome(1 day)
研究者
研究点 (1)
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