Real Time Determination of the Hill Grade During Gastroscopy Using Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Accuracy of assessments for the Hill classification for physicians and AI method.
研究概览
简要总结
The Hill classification, also known as the Hill grade, is a system used to classify the severity of gastroesophageal valve incompetence, specifically related to gastroesophageal reflux disease (GERD) and hiatal hernia. This study aims to compare the ability of physicians versus an AI model to asses the Hill grade during gastroscopy.
详细描述
Objective:
The primary goal of this study is to compare the accuracy in determining the Hill classification during gastroscopy between an artificial intelligence (AI) based system and physicians performing the examination. Secondary outcomes include evaluation of the per-class accuracy and other statistical measures such as precision, recall and f1 score.
Study Design:
Single center, endoscopist blinded study. The model considered in a previous study achieved a mean accuracy of 88%. All participants initially attended a lecture serving as a refresher regarding the Hill classification. Subsequently, physicians were asked to provide the Hill classification for test images expert annotated images depicting different Hill grades, achieving mean accuracy of 72%. Thus 127 paired measurements are required. Taking patient drop-out into consideration, at least 159 patients need to be recruited. Upon examination of the flap-valve during endoscopy, the physician is required to store an image of the flap-valve during retroflexion, which is part of the standard procedure, based on which they determine the Hill classification. The prediction of the AI model on this image is considered the model output and is considered the model's output. A group of three expert endoscopists determines the Hill classification for each image, based on majority vote, which is treated as the gold standard.
AI setup and limitations:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adult patients (>18 years)
- •Scheduled gastroscopy
排除标准
- •Examination level
- •Previous surgical interventions or altered anatomy that prevents the proper examination of the flap valve
- •Flap-valve not inspected
- •Data Level:
- •Image during flap-valve inspection not stored
- •Expert committee not resulting in a majority vote
结局指标
主要结局
Accuracy of assessments for the Hill classification for physicians and AI method.
时间窗: Through study completion, an average of 5 months
Binary assessment of physician vs AI correct and erroneous predictions.
次要结局
- Distance for label assessment from gold standard label.(Through study completion, an average of 5 months)
- Accuracy of assessments for each Hill grade for physicians and AI method.(Through study completion, an average of 5 months)
- Precision and recall of the assessments for each Hill from endoscopists and AI method.(Through study completion, an average of 5 months)