Prospective Study of Real-time Diagnosis of Colorectal Polyps Using Narrow-Band Imaging: Gangnam-ReaDi Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,268
- 试验地点
- 1
- 主要终点
- Concordance rate between optical diagnosis and histologic diagnosis for polyps <10 mm in real-time colonoscopy
研究概览
简要总结
Accurate optical diagnosis of colorectal polyps could allow a "resect and discard" strategy with surveillance intervals determined based on the results of the optical biopsy. The investigators perform education to characterize the histology of diminutive and small colorectal polyps by using narrow band imaging (NBI). After education program, the investigators prospectively evaluate real-time optical biopsy analysis of polyps with NBI by 15 gastroenterologists at a medical check up center.
详细描述
This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of four periods.
First, a computer based education program on the accuracy of predicting polyp histology with NBI (NICE and WASP classification) will be performed by 15 endoscopists (less experienced in NBI) during Septepber 2015.
In the second period from October 2015 till Deceber 2015, 1st phase real- time optical diagnosis for diminutive and small colorectal polyps will be activated. All endoscopists will have weekly feedback on their accuracy of optical diagnosis for polyps, and discuss the NBI findings that mismatched by histologic diagnosis all together per one month.
Third, the result of 1st phase real-time optical diagnosis will be analyzed from January 2016 till April 2016. In this period, endoscopists with low accuracy of 1st phase real-time optical diagnosis will be re-educated.
The last period from May 2016 till September 2016, 2nd phase real-time optical diagnosis for polyps will be activated. Performance will be evaluated by comparing optically predicted diagnosis with actual histologic diagnosis. Cumulative sum analysis will be used to determine the learning curve for each endoscopist. Negative predictive value for the prediction of nonneoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence will also be measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Customers who received screening and surveillance colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from October 2015 to September 2016.
排除标准
- •Age <18 years
- •Customers who refused to offer their health check up data
- •History of inflammatory bowel disease
- •History of familial adenomatous polyposis
- •Customers who received Incomplete colonoscopy
- •History of previous colorectal resection
- •Incomplete data collection on optical diagnosis
结局指标
主要结局
Concordance rate between optical diagnosis and histologic diagnosis for polyps <10 mm in real-time colonoscopy
时间窗: 12 month
次要结局
- Serrated lesion detection rate(24 month)
- Concordance rate in surveillance intervals of follow-up colonoscopy between optical diagnosis and histological diagnosis for polyps assessed with high confidence(12 months)
- Negative predictive value for neoplastic polyps in rectosigmoid polyps 5mm or smaller with assessed high confidence(12 months)
- The maintance of accuracy of optical diagnosis(12 months)
- Adenoma detection rate(24 month)
- The learning curve of accuracy of optical diagnosis(12 months)
研究者
Su Jin Chung
Associated Professor
Seoul National University Hospital