Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Interobserver agreement and diagnostic accuracy
研究概览
简要总结
The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria.
This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.
详细描述
Objective: Validate diagnostic impact of VLE diagnostic accuracy on clinical management
Primary Objectives:
- Interobserver study for criteria validation and accuracy, Positive predictive value (PPV) and Negative predictive value (NPV), sensitivity and specificity.
- Evaluation of VLE diagnostics on clinical management (increased accuracy/faster detection)
- Determination of learning curve to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management.
B. Hypotheses / Research Question(s) The new VLE criteria for biliary and pancreatic duct strictures increase accuracy, thus leading to substantial impact on clinical management (Screening and Treatment)
Study Design (2 phase):
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology -
排除标准
- 未提供
结局指标
主要结局
Interobserver agreement and diagnostic accuracy
时间窗: 2 months
Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity
Frequency and type of criteria visually identified on malignant VLE clips
时间窗: 2 months
Correlation analysis of any of the 9 visual criteria with malignancy diagnosis as determined by endoscopist
次要结局
- Number of procedures needed to view and conduct to use VLE for diagnostic confirmation(2 months)