Near-focus Versus Normal-focus Narrow Band Imaging Colonoscopy in Diagnosis of Colorectal Polyps Based on Combined NICE and WASP Classification: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.
研究概览
简要总结
Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively.
详细描述
Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were scheduled for colonoscopy at NKC institute
排除标准
- •Inflammatory bowel disease
- •Polyposis syndrome
- •Colorectal cancer
- •Active gastrointestinal bleeding
- •Pregnant woman
- •Inadequate bowel preparation
- •Contraindication for polyps removal
结局指标
主要结局
Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.
时间窗: At the time of procedure
Measure of the percentage od accurate predictions by the endoscopists in the differentiation of sessile serrated polyps/adenoma from hyperplastic polyps, using the high definition NBI colonoscopy with and without near focus features.
Rate of accurate polyp histology predictions by the Endoscopists in the two groups.
时间窗: At the time of procedure
Measure of the percentage of accurate predictions by the endoscopists in the differentiation of neoplastic from non neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without near focus features
次要结局
- The adenoma detection rate(At the time of procedure)
- The polyp detection rate(At the time of procedure)
- Diagnostic Characteristics(At the time of procedure)
研究者
Nisa Netinatsunton
Principal Investigation
Prince of Songkla University