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A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT02968069
Collaborator
Shanghai Putuo district Liqun hospital (Other), Shanghai MCC worker hospital (Other)
300
Enrollment
1
Arm
36
Duration (Months)

Study Details

Study Description

Brief Summary

Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.The investigators will conduct a study to develop and validate a diagnostic model based on NBI for early gastric cancerous lesions under endoscopic observation.

Condition or Disease Intervention/Treatment Phase
  • Device: NBI
 N/A

Detailed Description

Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for histological diagnosis of gastric epithelial neoplasia before proper management.Many studies have shown that there exist considerable discrepancies between EFB and subsequently resected specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be observed. Here, the investigators will conduct a study to develop and validate a diagnostic model based on narrow band imaging for early gastric cancerous lesions under endoscopic observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Development and Validation of a Predictive Model for Early Gastric Cancerous Lesions Under Endoscopic Observation
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Suspected gastric cancerous lesions

Magnifying endoscopy with NBI would be conducted for every patient included in our study

Device: NBI
Endoscopic factors under white light view and simplified narrow band imaging classification assisting in diagnosing cancerous lesions will be recorded.
Other Names:
  • Evis Lucera system (CV-260, Olympus Inc, Japan)
  • high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan)
  • magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions [36 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Suspected of having a cancerous lesions

    • The age of patients is from 40-80 years

    • Patients must undergo esophagogastroduodenoscopy

    Exclusion Criteria:

    • Clinical diagnosis of advanced gastric cancer

    • Acute upper gastrointestinal bleeding

    • Severe systemic diseases

    • Refuse to attend the study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine
    • Shanghai Putuo district Liqun hospital
    • Shanghai MCC worker hospital

    Investigators

    • Principal Investigator: Xiaobo Li, MD.Ph.D, Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaobo Li, Professor, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02968069
    Other Study ID Numbers:
    • 2016-138k
    First Posted:
    Nov 18, 2016
    Last Update Posted:
    Nov 18, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Nov 18, 2016