Carcinoma in Situ of Esophagus, Esophageal Squamous Cell Carcinoma, Mild Dysplasia of Esophagus, Moderate Dysplasia of Esophagus, Severe Dysplasia of Esophagus
Conditions
Keywords
Esophageal Squamous Cell Carcinoma, Population-level screening, Narrow Band Imaging, Iodine Staining, Sensitivity and Specificity
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.
Interventions
DIAGNOSTIC_TESTEndoscopic examination using white light, NBI and iodine staining
Participants' esophagus will be examined by three commonly used diagnostic techniques in the order of : 1. White light endoscopy (WLE); 2. Narrow Band Imaging (NBI) and 3. Iodine Staining Endoscopy (ISE) with 1.2% Lugol's iodine solution. The required observation time is no less than 1 minute for WLE and 2 minutes for NBI and ISE. Endoscopic images of each participant are routinely captured at every 5 centimeters in the esophagus, and information is recorded in detail for each focal lesion. Biopsies are taken from all visually abnormal areas found by any one of the three techniques, histopathologic diagnoses are rendered by two pathologists according to standard criteria and discrepancies are adjudicated by consultation. The recorded endoscopic images for each biopsied lesion are read by two trained researchers and the visualized feature of lesions are decomposed into several indicators (e.g. size, shape, color, and border of lesions) .
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus | 0 days | Sensitivity 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 | 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 | 0 days | PPV 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 | 0 days | NPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight of each visualized abnormal feature of lesions | 0 days | The estimated odds ratio of each decomposed graphic abnormal features of lesions, taking severe dysplasia and above diagnosed via histopathological analysis as the outcome events. |
| Discrimination of visualized abnormal features | 0 days | The area under the curve (AUC) of visualized graphic abnormal features for predicting severe dysplasia and above lesions. |
Countries
China
Contacts
Primary ContactYang Ke, MD
Backup ContactZhonghu He, PhD
Outcome results
None listed