Real-time Computer Aided Detection of Barrett's Neoplasia: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity
研究概览
简要总结
In the real-time pilot study, the performance of a recently developed Computer Aided Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic examination. Three expert endoscopists in the field of Barrett's esophagus and endoscopic resection techniques will perform the inclusions following a standardized data acquisition protocol. In total, 15 patients with a visible neoplastic lesion in their Barrett's esophagus and 15 patients without any visible abnormalities in their Barrett's esophagus will be included in this study. Outcomes: to investigate feasibility of the use of the CADe system in the endoscopy suite, to investigate the performance of the CADe system when used by endoscopists.
详细描述
Patients in this study will undergo a scheduled surveillance endoscopy (according to current guidelines; n = 15) or are referred to a tertiary referral center for endoscopic resection of a possible neoplastic area in their known Barrett's esophagus (n = 15).
Patients will be consciously sedated (standard care) before start of the procedure. During the endoscopic procedure, the endoscopist follows the standard protocol after extensive cleaning of the Barrett's segment: first, a standardized pullback video will be recorded, followed by a careful inspection of the Barrett segment every 2 centimeters. Per 2cm, a video of 10 seconds and 3 overview images are being recorded.
During the imaging protocol, the CADe system presents its prediction on a second screen, next to the main endoscopy monitor. After the imaging protocol, standard clinical care is being resumed.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years;
- •Patients under surveillance for their diagnosed non-dysplastic Barrett's esophagus or patients refered for endoscopic treatment because of proven high-grade dysplasia or adenocarcinoma;
- •A circumferential Barrett length of at least 2cm
排除标准
- •Medical history of prior surgical or endoscopical treatment for neoplasia in their esophagus
- •Reflux esophagitis > grade 2 (LA classification)
- •Inability to undergo endoscopic treatment and/or biopsies
结局指标
主要结局
Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity
时间窗: 5 months
To investigate the combined performance between endoscopist and CADe system on a per-patient level.
次要结局
- Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity(5 months)
研究者
prof. dr. J.J.G.H.M. Bergman
Professor of Gastroenterology
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)