Trial Outcomes & Findings for Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy (NCT NCT00795184)

Results Overview

Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

122 participants

Primary outcome timeframe

Centralized histopathology confirmation within 4-6 weeks

Results posted on

2016-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	HDWLE First NBI Second and pCLE	NBI First HDWLE Second and pCLE
Overall Study STARTED	65	57
Overall Study COMPLETED	57	44
Overall Study NOT COMPLETED	8	13

Reasons for withdrawal

Reasons for withdrawal
Measure	HDWLE First NBI Second and pCLE	NBI First HDWLE Second and pCLE
Overall Study Tissue sampling incomplete/conclusive	8	13

Baseline Characteristics

Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=101 Participants NBI-pCLE
Age, Continuous	65.1 years STANDARD_DEVIATION 11.52 • n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	87 Participants n=99 Participants
Region of Enrollment France	9 participants n=99 Participants
Region of Enrollment United States	62 participants n=99 Participants
Region of Enrollment Germany	30 participants n=99 Participants

PRIMARY outcome

Timeframe: Centralized histopathology confirmation within 4-6 weeks

Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.

Outcome measures

Outcome measures
Measure	HDWLE n=874 Biopsy sites	NBI (Narrow Band Imaging) n=874 Biopsy sites	pCLE n=874 Biopsy sites	HDWLE+NBI+pCLE n=874 Biopsy sites	HDWLE+pCLE n=874 Biopsy sites	HDWLE+NBI n=874 Biopsy sites
Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. Sensitivity	34.2 percentage of lesions Interval 25.7 to 42.7	41.7 percentage of lesions Interval 32.8 to 50.5	62.5 percentage of lesions Interval 53.8 to 71.2	75.8 percentage of lesions Interval 68.2 to 83.5	68.3 percentage of lesions Interval 60.0 to 76.7	45.0 percentage of lesions Interval 36.1 to 53.9
Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. Specificity	92.7 percentage of lesions Interval 90.8 to 94.6	90.5 percentage of lesions Interval 88.4 to 92.5	92.7 percentage of lesions Interval 90.8 to 94.6	84.2 percentage of lesions Interval 81.6 to 86.8	87.8 percentage of lesions Interval 85.5 to 90.1	88.2 percentage of lesions Interval 85.9 to 90.5

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christophe Bailleul

Mauna Kea Technologies

Phone: + 33 1 70 08 09 74

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place