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

Peking University Cancer Hospital & Institute

Status: Unknown

Conditions: Carcinoma in Situ of Esophagus; Mild Dysplasia of Esophagus; Esophageal Squamous Cell Carcinoma; Severe Dysplasia of Esophagus; Moderate Dysplasia of Esophagus

Treatments: Diagnostic Test: Endoscopic examination using white light, NBI and iodine staining

Study type: Interventional

Funder types: Other

Identifiers

NCT04170257

2018KT111

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 45 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,000 participants in 1 patient group

Opportunistic screening cohort

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Endoscopic examination using white light, NBI and iodine staining