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

Not Applicable

• Conditions: Severe Dysplasia of Esophagus; Carcinoma in Situ of Esophagus; Moderate Dysplasia of Esophagus; Esophageal Squamous Cell Carcinoma; Mild Dysplasia of Esophagus
• Interventions: Diagnostic Test: Endoscopic examination using white light, NBI and iodine staining

• 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

Study Timeline

• Study Start: 2019-10-18
• Status Verified: 2019-11
• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-18
• Last Update Submitted: 2019-11-18
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Opportunistic screening cohort	Endoscopic examination using white light, NBI and iodine staining	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.

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)

People's Hospital of Hua County, Henan Province; 🇨🇳 Anyang, Henan, China

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Anyang Cancer Hospital; 🇨🇳 Anyang, Henan, China

People's Hospital of Ningxia Hui Autonomous Region; 🇨🇳 Yinchuan, Ningxia Hui Autonomous Region, China

Shantou University Medical College Affiliated Cancer Hospital; 🇨🇳 Shantou, Guangdong, China