Performance of White Light, NBI and Iodine Staining Endoscopy in the Diagnosis of Esophageal Lesions
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|ClinicalTrials.gov Identifier: NCT04170257|
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mild Dysplasia of Esophagus Moderate Dysplasia of Esophagus Severe Dysplasia of Esophagus Carcinoma in Situ of Esophagus Esophageal Squamous Cell Carcinoma||Diagnostic Test: Endoscopic examination using white light, NBI and iodine staining||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 18, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Opportunistic screening cohort
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.
Diagnostic Test: Endoscopic 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) .
- 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.
- 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.
- 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.
- Weight of each visualized abnormal feature of lesions [ Time Frame: 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 [ Time Frame: 0 days ]The area under the curve (AUC) of visualized graphic abnormal features for predicting severe dysplasia and above lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170257
|Contact: Yang Ke, MDemail@example.com|
|Contact: Zhonghu He, PhDfirstname.lastname@example.org|
|Beijing Friendship Hospital||Not yet recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Fandong Meng, MD|
|Shantou University Medical College Affiliated Cancer Hospital||Not yet recruiting|
|Shantou, Guangdong, China|
|Contact: Yi Guo, MD|
|Anyang Cancer Hospital||Recruiting|
|Anyang, Henan, China, 455000|
|Contact: Anxiang Liu, MD|
|People's Hospital of Hua County, Henan Province||Recruiting|
|Anyang, Henan, China, 456400|
|Contact: Yujie He, MD|
|China, Ningxia Hui Autonomous Region|
|People's Hospital of Ningxia Hui Autonomous Region||Not yet recruiting|
|Yinchuan, Ningxia Hui Autonomous Region, China|
|Contact: Shengjuan Hu, MD|
|Study Director:||Mengfei Liu, PhD||Beijing Cancer Hospital|