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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opportunistic screening cohort | Experimental | This opportunistic screening cohort is constructed among patients aged 45-69 years who undergo endoscopic examinations at the endoscopy center in any of the five hospitals included in this study. Enrolled participants are requested to complete a computer aided one-on-one questionnaire regarding demographic factors, smoking and alcohol drinking status, dietary habits，digestive tract symptoms and family history of ESCC. Then experienced endoscopists will perform the upper gastrointestinal endoscopic examination for each participant, and the entire esophagus will be visually examined with the white light, NBI and iodine staining endoscopic examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic examination using white light, NBI and iodine staining | Diagnostic Test | 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) . |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus | Sensitivity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard. | 0 days |
| Specificity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus | Specificity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard. | 0 days |
| Positive predictive value (PPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus | PPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard. | 0 days |
| Negative predictive value (NPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus | NPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard. | 0 days |
| Measure | Description | Time Frame |
|---|---|---|
| Weight of each visualized abnormal feature of lesions | 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. | 0 days |
| Discrimination of visualized abnormal features |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Ke, MD | Contact | 86-10-88196762 | keyang@bjmu.edu.cn | |
| Zhonghu He, PhD | Contact | 86-10-88196762 | zhonghuhe@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mengfei Liu, PhD | Peking University Cancer Hospital & Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100050 | China |
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|
The area under the curve (AUC) of visualized graphic abnormal features for predicting severe dysplasia and above lesions. |
| 0 days |
| Shantou University Medical College Affiliated Cancer Hospital | Not yet recruiting | Shantou | Guangdong | China |
|
| Anyang Cancer Hospital | Recruiting | Anyang | Henan | 455000 | China |
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| People's Hospital of Hua County, Henan Province | Recruiting | Anyang | Henan | 456400 | China |
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| People's Hospital of Ningxia Hui Autonomous Region | Not yet recruiting | Yinchuan | Ningxia | China |
|
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D062048 | Narrow Band Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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