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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182804
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Device: Olympus Device: Cellvizio Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
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 Start Date : February 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study
probe-based confocal laser endomicroscopy narrow band imaging with magnification
Device: Olympus
narrow band imaging with magnification

Device: Cellvizio
probe-based confocal laser endomicroscopy




Primary Outcome Measures :
  1. Accuracy [ Time Frame: an expected average of 2 weeks ]
    Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02182804


Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Chulalongkorn University
Investigators
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Principal Investigator: Rapat Pittayanon, M.D. King Chulalongkorn Memorial Hospital

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Responsible Party: Rapat Pittayanon, MD, Gastroenterologist, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT02182804    
Other Study ID Numbers: RP008
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital:
Confocal Laser Endomicroscopy
Narrow Band Imaging
Lugol Chromoendoscopy
Esophageal Neoplasm
Head and Neck Cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases