A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer
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.
1 other identifier
interventional
44
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 8, 2014
CompletedResults Posted
Study results publicly available
August 28, 2020
CompletedAugust 28, 2020
August 1, 2020
1.3 years
July 1, 2014
August 13, 2020
August 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy
Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.
an expected average of 2 weeks
Study Arms (1)
Study
EXPERIMENTALprobe-based confocal laser endomicroscopy narrow band imaging with magnification
Interventions
Eligibility Criteria
You may qualify if:
- Age over 20 years
- Having histological-confirmed diagnosis of head and neck cancer
- Having no esophageal symptoms
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King Chulalongkorn Memorial Hospitallead
- Chulalongkorn Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This was a pilot study and the sample size was small. We did not randomly assign the order of dNBI and pCLE. The unwashed Lugol's stain significantly influenced the observation of IPCL structure on dNBI study.
Results Point of Contact
- Title
- Dr. Piyapan Prueksapanich
- Organization
- Division of Gastroenterology. Department of Medicine. Faculty of Medicine. Chulalongkorn University.
Study Officials
- PRINCIPAL INVESTIGATOR
Rapat Pittayanon, M.D.
King Chulalongkorn Memorial Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gastroenterologist
Study Record Dates
First Submitted
July 1, 2014
First Posted
July 8, 2014
Study Start
February 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 28, 2020
Results First Posted
August 28, 2020
Record last verified: 2020-08