Trial Outcomes & Findings for A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer (NCT NCT02182804)

Results Overview

Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

an expected average of 2 weeks

Results posted on

2020-08-28

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 milestones

Participant milestones
Measure	Study Arm Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Arm n=44 Participants Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.
Age, Continuous	60 years STANDARD_DEVIATION 12 • n=44 Participants
Sex: Female, Male Female	6 Participants n=44 Participants
Sex: Female, Male Male	38 Participants n=44 Participants
Region of Enrollment Thailand	44 Participants n=44 Participants

PRIMARY outcome

Timeframe: an expected average of 2 weeks

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

Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.

Outcome measures

Outcome measures
Measure	Study Arm n=21 Lugol's voiding lesion Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.
Accuracy dNBI	70 Percentage of accuracy Interval 48.0 to 85.0
Accuracy pCLE	89 Percentage of accuracy Interval 67.0 to 97.0

Adverse Events

Study Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Arm n=44 participants at risk Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.
Surgical and medical procedures Bleeding	2.3% 1/44 • Number of events 1 • Intraprocedural.

Additional Information

Dr. Piyapan Prueksapanich

Division of Gastroenterology. Department of Medicine. Faculty of Medicine. Chulalongkorn University.

Phone: 6622564000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place