CClinicalTrials.gg
CompletedNCT02182804Updated Aug 28, 2020Results posted

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

An interventional study of Olympus and Cellvizio in Esophageal Neoplasms, sponsored by King Chulalongkorn Memorial Hospital. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-08-28.

Sponsored by King Chulalongkorn Memorial Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Esophageal Neoplasms

Keywords

  • Confocal Laser Endomicroscopy
  • Narrow Band Imaging
  • Lugol Chromoendoscopy
  • Esophageal Neoplasm
  • Head and Neck Cancer
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 44 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

King Chulalongkorn Memorial Hospital is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Study

    probe-based confocal laser endomicroscopy narrow band imaging with magnification

    Device: Olympus · Device: Cellvizio

Interventions

  • DeviceOlympus

    narrow band imaging with magnification

  • DeviceCellvizio

    probe-based confocal laser endomicroscopy

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Aug 28, 2020
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.

Participant flow

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).

Participant flow — Overall Study
MilestoneStudy Arm
Started44
Completed44
Not completed0

Outcome measures

PrimaryAccuracy

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
Reported as:
Number · Percentage of accuracy
Accuracy
Percentage of accuracyStudy Arm
pCLE89 (67 to 97)
dNBI70 (48 to 85)

Adverse events

Collected over Intraprocedural.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Study Arm0/44 (0%)0/44 (0%)1/44 (2.3%)
Most frequent other events
Most frequent other events
EventStudy Arm
BleedingSurgical and medical procedures1/44

Baseline characteristics

Age, Continuous
Age, Continuous(years)Study Arm
Mean60 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)Study Arm
Female6
Male38
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Study Arm
Region of Enrollment
Region of Enrollment(Participants)Study Arm
Thailand44
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02182804
Lead sponsor
King Chulalongkorn Memorial Hospital
Collaborators
Chulalongkorn University
Responsible party
Rapat Pittayanon (Gastroenterologist, King Chulalongkorn Memorial Hospital) — Principal investigator
First posted
Jul 8, 2014
Start date
Feb 2013
Primary completion
Jun 2014
Completion
Jun 2014
Results posted
Aug 28, 2020
Last update
Aug 28, 2020

Study contacts

Rapat Pittayanon, M.D.
principal investigator · King Chulalongkorn Memorial Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion