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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02182804
Enrollment
44
Registered
2014-07-08
Start date
2013-02-28
Completion date
2014-06-30
Last updated
2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms

Keywords

Confocal Laser Endomicroscopy, Narrow Band Imaging, Lugol Chromoendoscopy, Esophageal Neoplasm, Head and Neck Cancer

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.

Interventions

DEVICEOlympus

narrow band imaging with magnification

DEVICECellvizio

probe-based confocal laser endomicroscopy

Sponsors

Chulalongkorn University
CollaboratorOTHER
King Chulalongkorn Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracyan expected average of 2 weeksDiagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.

Participant flow

Recruitment details

There were 631 patients with a previous history of head and neck cancer in the 10-year record. Of the 631 patients, 587 were excluded for the following reasons: patients could not be contacted (n=458), death (n=72), esophageal obstruction or stricture, previous esophageal surgery (n=34), and patients who refused to participate (n=23).

Participants by arm

ArmCount
Study Arm
Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.
44
Total44

Baseline characteristics

CharacteristicStudy Arm—
Age, Continuous60 years
STANDARD_DEVIATION 12
—
Race and Ethnicity Not Collected—— Participants
Region of Enrollment
Thailand
44 Participants—
Sex: Female, Male
Female
6 Participants—
Sex: Female, Male
Male
38 Participants—

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 44
other
Total, other adverse events
1 / 44
serious
Total, serious adverse events
0 / 44

Outcome results

Primary

Accuracy

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

Population: Twenty-one Lugol's voiding lesions larger than 5mm were detected in 12 patients.

ArmMeasureGroupValue (NUMBER)
Study ArmAccuracypCLE89 Percentage of accuracy
Study ArmAccuracydNBI70 Percentage of accuracy

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026