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

• Conditions: 1) Barrett oesophagus; 2) early oesophageal cancer; 10017990; 10017991

• Registration Number: NL-OMON34541
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

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

- 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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