Performance of White Light, Narrow Band Imaging and Iodine Staining Endoscopy in the Diagnosis of Esophageal Squamous Epithelium Lesions: A Multicenter Clinical Study in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Dysplasia of Esophagus
- Sponsor
- Peking University Cancer Hospital & Institute
- Enrollment
- 10000
- Locations
- 5
- Primary Endpoint
- Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
- Last Updated
- 6 years ago
Overview
Brief Summary
The investigators aim to evaluate the performance of Narrow Band Imaging (NBI) endoscopy in Esophageal Squamous Cell Carcinoma (ESCC) screening, as compared to the currently used White Light Endoscopy (WLE) and Lugol's Iodine Staining Endoscopy (ISE). NBI is a simple, safe and non-invasive technique, which can provide real-time optical staining for suspicious lesions. This trial is designated to enroll 10000 participants from five centers located in different regions (North, West and South) in China, which would provide real-world evidence for the recommendation of endoscopic diagnostic technique used in ESCC screening projects.
Investigators
Yang Ke
Professor
Peking University Cancer Hospital & Institute
Eligibility Criteria
Inclusion Criteria
- •Patients seek for endoscopic examinations at the endoscopy center in any of the five hospitals included in this study
- •Aged 45-69 years
- •Have entire esophagus
- •Provide written informed consent and leave personal identification and contact information
Exclusion Criteria
- •Have contraindications to endoscopic examination (Including but not limited to severe arrhythmia, myocardial infarction, heart failure, hemiplegia, asthma, severe hypertension (≥ 180 / 110mmHg), psychosis, etc )
- •Have a history of drug allergy
- •Have a history of upper gastrointestinal surgery
- •Have a history of radiotherapy or chemotherapy
Outcomes
Primary Outcomes
Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Time Frame: 0 days
Sensitivity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Negative predictive value (NPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Time Frame: 0 days
NPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Specificity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Time Frame: 0 days
Specificity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Positive predictive value (PPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Time Frame: 0 days
PPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Secondary Outcomes
- Weight of each visualized abnormal feature of lesions(0 days)
- Discrimination of visualized abnormal features(0 days)