Barrett's oesophagus Cancer Oesophageal cancer
Conditions
Interventions
As part of this study, patients referred with flat Barrett’s oesophagus without evidence of visible lesions receive two endoscopies in a randomised order (standard procedure and experimental procedure
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Added value of the use of molecular biomarkers to the optical biopsy for the diagnosis of any grade of dysplasia. This will be measured by testing molecular biomarkers on tissue biopsies. The biomarkers result will be integrated with that of the optical diagnosis and the results will be compared with that of the gold standard histologic diagnosis. 2. Diagnostic accuracy for any grade of dysplasia of a panel of biomarkers performed on AFI-targeted biopsies. This will be measured by testing molecular biomarkers on tissue biopsies and comparing the results with the gold standard histologic diagnosis 3. Time to perform AFI-targeted pCLE vs gold standard (Seattle protocol). This will be measured as time from the beginning to the end of each endoscopic procedure. Standard and experimental procedure time will be compared. 4. Costs to perform AFI-targeted pCLE +/- biomarkers and conventional endoscopic surveillance with Seattle protocol. This will be measured by the costs of a single use of pCLE probe and laboratory costs of molecular biomarkers for the experimental procedure and costs for processing biopsies and costs of pathology time for histologic diagnosis for the standard procedure. 5. Patient-reported experience and outcome measures, including acceptability and anxiety levels. This outcome will be measured using 2 validated questionnaires: a 10-point visual analogue scale (VAS, 0 = worst and 10 = best), filled by participants before and after each procedure and 6-item state-trait anxiety inventory (STAI -6), completed after each procedure. | — |
Countries
England, United Kingdom
Contacts
Public ContactMichele Bianchi
Outcome results
None listed