NCT04170257

Performance of White Light, NBI and Iodine Staining Endoscopy in the Diagnosis of Esophageal Lesions

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 45 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mild Dysplasia of Esophagus
• Moderate Dysplasia of Esophagus
• Severe Dysplasia of Esophagus
• Carcinoma in Situ of Esophagus
• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
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) .

Timeline

• Start date: 2019-10-18
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-11-20
• Last updated: 2019-11-20

Locations

5 sites across 1 country: China