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

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ClinicalTrials.gov Identifier: NCT04170257
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yang Ke, Beijing Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Mild Dysplasia of Esophagus Moderate Dysplasia of Esophagus Severe Dysplasia of Esophagus Carcinoma in Situ of Esophagus Esophageal Squamous Cell Carcinoma Diagnostic Test: Endoscopic examination using white light, NBI and iodine staining Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Iodine

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) .




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170257


Contacts
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Contact: Yang Ke, MD 86-10-88196762 keyang@bjmu.edu.cn
Contact: Zhonghu He, PhD 86-10-88196762 zhonghuhe@foxmail.com

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

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Responsible Party: Yang Ke, Professor, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT04170257    
Other Study ID Numbers: 2018KT111
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yang Ke, Beijing Cancer Hospital:
Esophageal Squamous Cell Carcinoma
Population-level screening
Narrow Band Imaging
Iodine Staining
Sensitivity and Specificity
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Carcinoma in Situ
Hyperplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pathologic Processes
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs