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| Name | Class |
|---|---|
| Chulalongkorn University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Experimental | probe-based confocal laser endomicroscopy narrow band imaging with magnification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olympus | Device | narrow band imaging with magnification |
| |
| Cellvizio |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rapat Pittayanon, M.D. | King Chulalongkorn Memorial Hospital | Principal Investigator |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Arm | Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm | Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy | Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters. | Twenty-one Lugol's voiding lesions larger than 5mm were detected in 12 patients. | Posted | Number | 95% Confidence Interval | Percentage of accuracy | an expected average of 2 weeks | Lugol's voiding lesion | Lugol's voiding lesion |
|
|
Intraprocedural.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Arm | Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Surgical and medical procedures | Systematic Assessment | One patient developed bleeding after biopsy and was successfully treated with endoscopic clipping. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Piyapan Prueksapanich | Division of Gastroenterology. Department of Medicine. Faculty of Medicine. Chulalongkorn University. | 6622564000 | 81001 | mpkus1@gmail.com |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Device |
probe-based confocal laser endomicroscopy |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
|
| Lugol's voiding lesion |
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 1 |
| 44 |
|
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| D004066 |
| Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |