Polyp Size Measurement During Real-time Colonoscopy Using the Virtual Scale Function SCALE EYE: Variability and Systematic Differences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Differences in residual variance expert endoscopists
研究概览
简要总结
Size of colorectal polyps is important to decide on appropriate surveillance intervals and treatment modality, as well as carrying out optical diagnosis strategies. However, polyp size measurement is often prone to inter-observer variability. An easy and accurate tool to assist in polyp size measurement is required. Recently, a virtual scale function for size measurement during endoscopy (SCALE EYE), operating in real-time without the use of any additional devices, has been developed. The aim of this study is to assess whether use of the SCALE EYE for polyp size measurement can reduce inter-observer variability.
详细描述
This study is designed as a single center prospective study. Polyp size measurements using SCALE EYE will be compared with several other polyp size measurement techniques: size measurements by endoscopists without a reference ('carpenters eye') , size measurements by endoscopists with an opened snare (of known size) as reference and size measurements by the pathologist during histopathological analysis.
During screening colonoscopies, detected polyps (maximum of four per colonoscopy) will be measured using all three different colonoscopy measurement techniques. This will be done by experienced endoscopists (endoscopist accredited for colonoscopies within the national colorectal cancer screening program). Since endoscopists measure polyps in multiple ways, consecutive measurements of the same polyp will be biased. For this reason, all polyp size measurements will be recorded on video. The video recordings of the different measurements of all polyps will be presented to eight expert endoscopists and four to eight trainees (depending on availability) in a randomized order. The size estimations based on these video recordings will be used for further analysis. Histopathological analysis and size measurements of the resected polyps will be performed by pathologists with expertise in gastrointestinal pathology. Variability and systematic differences in polyp size measurement between different measurements methods will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Age >18 years
- •Screening colonoscopy after positive fecal immunochemical test (FIT) within the Dutch colorectal cancer screening program
- •Signed informed consent
排除标准
- •Diagnosis of inflammatory bowel disease, Lynch syndrome or (serrated) polyposis syndrome
结局指标
主要结局
Differences in residual variance expert endoscopists
时间窗: Through study completion, an average of 3 months
The difference in residual variance (variability) between (1) polyp size measurement with SCALE EYE and (2) polyp size measurement using an opened snare (of known size) as reference.
次要结局
- SCALE EYE satisfaction score(Through study completion, estimation: 3 months)
- Systematic differences expert endoscopists(Through study completion, estimation: 3 months)
- Differences in residual variance and systematic differences trainees(Through study completion, estimation: 3 months)
- Inter-observer variability(Through study completion, estimation: 3 months)
- SCALE EYE measurement accuracy compared to snare measurement(Through study completion, estimation: 3 months)
- SCALE EYE measurement accuracy compared to snare measurement for different polyp size groups(Through study completion, estimation: 3 months)
- SCALE EYE success rate(Through study completion, estimation: 3 months)
- SCALE EYE measurement time(Through study completion, estimation: 3 months)
- Differences in residual variance expert endoscopists(Through study completion, estimation: 3 months)
研究者
Prof. Evelien Dekker, MD, PhD
Prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)