Performance of White Light, NBI and Iodine Staining Endoscopy in the Diagnosis of Esophageal Lesions
- Conditions
- Severe Dysplasia of EsophagusCarcinoma in Situ of EsophagusModerate Dysplasia of EsophagusEsophageal Squamous Cell CarcinomaMild Dysplasia of Esophagus
- Registration Number
- NCT04170257
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (5)
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Shantou University Medical College Affiliated Cancer Hospital
🇨🇳Shantou, Guangdong, China
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
People's Hospital of Hua County, Henan Province
🇨🇳Anyang, Henan, China
People's Hospital of Ningxia Hui Autonomous Region
🇨🇳Yinchuan, Ningxia Hui Autonomous Region, China
Beijing Friendship Hospital🇨🇳Beijing, Beijing, ChinaFandong Meng, MDContact