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

NCT ID: NCT04170257

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2022-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Endoscopic examination using white light, NBI and iodine staining

Intervention Type: DIAGNOSTIC_TEST

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) .

Interventions

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) .

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Yang Ke

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mengfei Liu, PhD

Role: STUDY_DIRECTOR

Peking University Cancer Hospital & Institute

Locations

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

Shantou University Medical College Affiliated Cancer Hospital

Shantou, Guangdong, China

Site Status: NOT_YET_RECRUITING

Anyang Cancer Hospital

Anyang, Henan, China

Site Status: RECRUITING

People's Hospital of Hua County, Henan Province

Anyang, Henan, China

Site Status: RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Yang Ke, MD

Role: CONTACT

keyang@bjmu.edu.cn

86-10-88196762

Zhonghu He, PhD

Role: CONTACT

zhonghuhe@foxmail.com

86-10-88196762

Facility Contacts

Fandong Meng, MD

Role: primary

Yi Guo, MD

Role: primary

Anxiang Liu, MD

Role: primary

Yujie He, MD

Role: primary

Shengjuan Hu, MD

Role: primary

Other Identifiers

2018KT111

Identifier Type: -

Identifier Source: org_study_id