跳至主要内容
临床试验/NCT02641509
NCT02641509终止不适用

Accuracy in Resection of Non-pedunculated Colonic Lesions 5-20 mm With/Without Using NBI

Valduce Hospital2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
113
试验地点
2
主要终点
NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion

研究概览

简要总结

Interval colon cancers are an important clinical issue. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology. In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.

详细描述

Interval colon cancers are an important clinical issue. Literature dealing with technics and quality of polypectomy is scarce. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy and factors related to it, revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology (the majority of non completely resected ones, were polyps of 10-20 mm and with serrated characteristics at the histology). In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
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

入选标准

  • Every polyp ≥ 5 mm and ≤ 20 mm

排除标准

  • Inflammatory bowel Disease and/or International Normalized Ratio > 1.5

结局指标

主要结局

NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
Valduce Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alida Andrealli

MD

Valduce Hospital

研究点 (2)

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