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

November 18, 2019 updated by: Yang Ke, Peking University Cancer Hospital & Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Not yet recruiting
        • Beijing Friendship Hospital
        • Contact:
          • Fandong Meng, MD
    • Guangdong
      • Shantou, Guangdong, China
        • Not yet recruiting
        • Shantou University Medical College Affiliated Cancer Hospital
        • Contact:
          • Yi Guo, MD
    • Henan
      • Anyang, Henan, China, 455000
        • Recruiting
        • Anyang Cancer Hospital
        • Contact:
          • Anxiang Liu, MD
      • Anyang, Henan, China, 456400
        • Recruiting
        • People's Hospital of Hua County, Henan Province
        • Contact:
          • Yujie He, MD
    • Ningxia Hui Autonomous Region
      • Yinchuan, Ningxia Hui Autonomous Region, China
        • Not yet recruiting
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
          • Shengjuan Hu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 days
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.
0 days
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.
0 days
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.
0 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 days
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.
0 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Study Director: Mengfei Liu, PhD, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018KT111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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