Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 281
- 试验地点
- 6
- 主要终点
- Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm
研究概览
简要总结
We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high definition white light colonoscopy will detect an increased number of nonpolypoid (flat and depressed) colorectal neoplasm.
详细描述
Interval colorectal cancers diagnosed within a three year period following a clearing colonoscopy have been reported at a rate of 1 cancer/1000 person years.The majority of these cancers are likely a consequence of a missed neoplastic lesion during routine colonoscopy. Recent tandem colonoscopy studies have shown no significant difference in adenoma miss or detection rates using narrow band imaging as compared to colonoscopy using white light. However, higher detection of flat neoplastic lesions using NBI was shown in a meta-analysis and should be furthered studied, especially considering that they are thought to be a strong contributor to a false negative colonoscopy.
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
- Single (Participant)
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
- •Adult patients referred for routine colonoscopy are eligible
排除标准
- •Known Inflammatory bowel disease
- •Referred for endoscopic evaluation and removal of colorectal lesion
- •Personal or family history of polyposis or non-polyposis syndrome
- •Presentation for emergency endoscopy
- •Inability to remove polyp due to coagulopathy or thrombocytopenia
- •Inability to provide informed consent
研究组 & 干预措施
High Definition NBI Colonoscopy
Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
干预措施: Olympus Colonoscope CFHQ190AL (Device)
High Definition White Light Colonoscopy
Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
干预措施: Olympus Colonoscope CFHQ190AL (Device)
结局指标
主要结局
Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm
时间窗: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.
次要结局
- Percentage of Nonpolypoid (Flat) Missed Lesions(One week (time of procedure plus time for pathology of polyp to be analyzed by histology))
- Percentage of Missed Lesions on Index Colonoscopy.(One week (time of procedure plus time for pathology of polyp to be analyzed by histology))
研究者
Roy Soetikno
Co-Principal Investigator
VA Palo Alto Health Care System