AFI-targeted confocal endomicroscopy in Barrett's oesophagus

Not Applicable

Completed

• Conditions: Oesophageal cancer; Barrett's oesophagus; Cancer

• Registration Number: ISRCTN16366217
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-25
• Study Completion: 2020-02-29
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. Able to read, comprehend, and complete the consent form
2. Aged =18
3. Diagnosed with dysplastic or non-dysplastic BO at least 2 cm in length if circumferential (C2) or 3 cm if not circumferential (M3)

Exclusion Criteria

1. Oesophagitis (Los Angeles grade =B)
2. Previous oesophagectomy or known oesophageal abnormality (e.g. fistula or severe oesophageal stricture)
3. Previous evidence of oesophageal adenocarcinoma
4. Previous history of endoscopically visible BO-related neoplasia
5. Known allergy to fluorescein
6. Severe or uncontrolled asthma
7. Coagulopathy or anticoagulant/antiplatelet therapy for high risk conditions
8. Active or severe cardiopulmonary disease or decompensated liver disease
9. Pacemaker or other intra-cardiac electric device

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The diagnostic accuracy for any grade of dysplasia of pCLE is measured comparing real-time optical diagnosis of dysplasia by pCLE on AFI-positive areas (experimental procedure) with the gold standard histologic diagnosis (overall pathological diagnosis from experimental and standard procedures).