Assessment of a Consensus Driven Narrow Band Imaging (NBI) Pattern Classification System in Barrett's Esophagus (BE)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus.
研究概览
简要总结
Narrow Band Imaging(NBI) improves image contrast by allowing the blue light centered at 415 nanometers which is heavily absorbed by oxyhemoglobin to highlight the tissue's microvasculature and enhances detail on the surface of the mucosa revealing subtle changes. Barrett's esophagus(BE) has the mucosal and vessel changes during cancer transformation by angiogenesis. The ability of the NBI scope to visualize submucosal vessels forms the premise for the prediction of dysplasia in BE mucosa.
NBI images of the BE mucosa obtained during endoscopy will be classified by academic endoscopists and community endoscopists initially. The endoscopists will then be asked to predict histopathology based on the NBI surface patterns. This clinical trial will evaluate the inter-observer agreement of a simple, consensus driven narrow band imaging (NBI) classification system of surface patterns and its ability to differentiate dysplastic versus non-dysplastic Barrett's esophagus(BE) in patients undergoing BE screening or surveillance in expert academic centers and in community GI practice as well. Their performance will be evaluated for accuracy, sensitivity, specificity, positive predictive value and negative predictive value of each pattern that is visualized on NBI.
详细描述
This is a multicenter, prospective, double-blinded study of NBI images from 50 patients enrolled in the study. Patients undergoing BE screening and BE surveillance will be enrolled into the study. After meeting eligibility criteria, and obtaining an informed consent, patients will undergo their routine upper endoscopic examination using white light endoscopy. During the course of the upper endoscopy, the BE surface patterns will be carefully examined with the endoscope in overview mode (with the endoscope in the center of the esophageal lumen) and then in close proximity to the BE surface (approximately 3-5 mm away from the mucosa). In each of these positions, a maximum of 4 high quality images will be obtained from different surface patterns initially with WLE and then using NBI. Image capture will be standardized. All the images will be classified based upon a simplified NBI classification system using two main criteria:(1)mucosal pattern(regular/irregular/uncertain) and (2)vascular pattern (regular/irregular/uncertain). All images will be captured using a high-definition, NBI endoscope (190 endoscopes-GIF-HQ 190 [dual focus],Olympus Inc) and stored in the high quality TIFF format. After images have been obtained, target biopsies will be obtained from each area and submitted for histopathological evaluation in separate jars. From the reports on NBI patterns from the images by Gastroenterologist and corresponding histopathological details, the accuracy and interobserver agreement of this NBI classification system will be determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Patients age: ≥ 18 years
- •Undergoing endoscopy for surveillance or endoscopic treatment of Barrett's esophagus
- •Ability to take oral proton pump inhibitor
- •For female subjects of childbearing potential, a negative urine pregnancy test within 2 weeks of enrollment and any subsequent endoscopy encounter
- •Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan
- •Ability to discontinue Aspirin/NSAIDs/Clopidogrel 7 days before and after all ablation procedures
- •Ability to provide written, informed consent and understands the responsibilities of trial participation
排除标准
- •The subject is pregnant or planning a pregnancy during the study period (12 months after treatment)
- •Esophageal stricture preventing passage of endoscope or catheter
- •Active erosive esophagitis
- •Prior endoscopic therapy with endoscopic mucosal resection, radiofrequency ablation, etc.
- •History of esophageal varices or coagulopathy
- •Prior radiation therapy to the esophagus, except head and neck region radiation therapy.
- •Evidence of esophageal varices during treatment endoscopy
- •Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
- •The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the current study.
- •Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol
结局指标
主要结局
Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus.
时间窗: 12 months
Identifying newer consensus driven NBI classification system in Barrett's esophagus for better inter observer agreement among experts and community/general gastroenterologists. Higher interobserver agreement (measured by Landis and Koch method) on these NBI patterns in Barrett's esophagus will help in diagnosing dysplasia in an uniform way among the gastroenterologists.
次要结局
- Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.(12 months)
- Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.(12 months)
- Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.(12 months)
- Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality.(12 months)
- Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.(12 months)
研究者
PRATEEK SHARMA
Principal Investigator
Midwest Biomedical Research Foundation