Autofluorescence endoscopy and spectroscopy for detection of early Barrett's neoplasia: the AFI-III study

Autofluorescence endoscopy and spectroscopy for detection of early Barrett's neoplasia: the AFI-III study - the AFI III study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34541

Enrollment

Registered

2010-06-21

Start date

2010-06-01

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

1) Barrett oesophagus 2) early oesophageal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age > 18 years; - BO with a minimal circumferential length of 3 cm; - BO without dysplasia (NDBO), BO with LGIN, or patients with BO referred for endoscopic work-up of HGIN or EC; - Signed informed consent

Exclusion criteria

Exclusion criteria: - Prior history of surgical or endoscopic treatment for oesophageal neoplasia; - Presence of erosive oesophagitis (Los Angeles classification *B); - Inability to obtain biopsies (e.g. due to anticoagulation, coagulation disorders, varices); - Unable to provide signed informed consent.

Design outcomes

Primary

Measure	Time frame
Phase 1: 1) Correlation of the ex-vivo spectroscopy data with histological outcome Phase 2: 1) Reduction of the false positive rate of WLE and AFI-III compared to WLE and AFI-II. 2) Reduction of the false positive rate of WLE and AFI-II with NBI 3) Reduction of the false positive rate of WLE and AFI-III with NBI 4) Reduction of the false positive rate of WLE and AFI-III with in-vivo spectroscopy 5) Correlation of the in-vivo spectroscopy data with histological outcome. 6) The amount of lesions detected with WLE and AFI III compared to WLE and AFI II	—

Measure

Time frame

Phase 1: 1) Correlation of the ex-vivo spectroscopy data with histological outcome Phase 2: 1) Reduction of the false positive rate of WLE and AFI-III compared to WLE and AFI-II. 2) Reduction of the false positive rate of WLE and AFI-II with NBI 3) Reduction of the false positive rate of WLE and AFI-III with NBI 4) Reduction of the false positive rate of WLE and AFI-III with in-vivo spectroscopy 5) Correlation of the in-vivo spectroscopy data with histological outcome. 6) The amount of lesions detected with WLE and AFI III compared to WLE and AFI II

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Countries

Netherlands

Outcome results