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A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer

Primary Purpose

Esophageal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Olympus
Cellvizio
Sponsored by
King Chulalongkorn Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Neoplasms focused on measuring Confocal Laser Endomicroscopy, Narrow Band Imaging, Lugol Chromoendoscopy, Esophageal Neoplasm, Head and Neck Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age over 20 years
  • Having histological-confirmed diagnosis of head and neck cancer
  • Having no esophageal symptoms

Exclusion Criteria:

  • Having index cancer of nasopharynx
  • History of esophageal surgery
  • Having esophageal stricture or obstruction
  • Having esophageal varices
  • Known case of esophageal cancer
  • Uncorrectable coagulopathy and thrombocytopenia
  • Pregnancy
  • Thyrotoxicosis
  • Creatinine clearance less than 30 ml/min
  • Allergy to iodine or fluorescein.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study

    Arm Description

    probe-based confocal laser endomicroscopy narrow band imaging with magnification

    Outcomes

    Primary Outcome Measures

    Accuracy
    Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 1, 2014
    Last Updated
    August 13, 2020
    Sponsor
    King Chulalongkorn Memorial Hospital
    Collaborators
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02182804
    Brief Title
    A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer
    Official Title
    Diagnostic Values of Probe-based Confocal Laser Endomicroscopy (pCLE) and Magnifying Narrow Band Imaging (M-NBI) for Early Neoplasms Detection in Esophageal Lugol'S-voiding Lesions.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Chulalongkorn Memorial Hospital
    Collaborators
    Chulalongkorn University

    4. Oversight

    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This descriptive cross sectional study aims to directly compare the diagnostic capability of the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging (M-NBI) in the Lugol's voiding lesions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Neoplasms
    Keywords
    Confocal Laser Endomicroscopy, Narrow Band Imaging, Lugol Chromoendoscopy, Esophageal Neoplasm, Head and Neck Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study
    Arm Type
    Experimental
    Arm Description
    probe-based confocal laser endomicroscopy narrow band imaging with magnification
    Intervention Type
    Device
    Intervention Name(s)
    Olympus
    Intervention Description
    narrow band imaging with magnification
    Intervention Type
    Device
    Intervention Name(s)
    Cellvizio
    Intervention Description
    probe-based confocal laser endomicroscopy
    Primary Outcome Measure Information:
    Title
    Accuracy
    Description
    Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.
    Time Frame
    an expected average of 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age over 20 years Having histological-confirmed diagnosis of head and neck cancer Having no esophageal symptoms Exclusion Criteria: Having index cancer of nasopharynx History of esophageal surgery Having esophageal stricture or obstruction Having esophageal varices Known case of esophageal cancer Uncorrectable coagulopathy and thrombocytopenia Pregnancy Thyrotoxicosis Creatinine clearance less than 30 ml/min Allergy to iodine or fluorescein.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rapat Pittayanon, M.D.
    Organizational Affiliation
    King Chulalongkorn Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer

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