Objective: The biggest challenge in endoscopic surveillance of Barrett’s esophagus (BE) is better detection of neoplasia in mucosa of normal macroscopic appearance. We evaluated in-vivo miniprobe confocal laser microscopy (CLM) for the detection of invisible Barrett neoplasia.
Design: Prospective two-center trial in two phases: Phase I to establish criteria of Barrett neoplasia and phase II to test these criteria.
Patients and Intervention: 296 biopsy sites in 38 consecutive BE patients (mean age 62.1 years, 89.5% men, median BE length 3 cm) were examined with standard high resolution endoscopy and by miniprobe CLM, with precise matching of CLM recordings to biopsy sites. CLM image criteria for normal versus neoplastic BE were established from 95 biopsies of 15 patients (phase I); these criteria were then prospectively tested on 201 biopsies from the remaining patients without visible focal changes (phase II). All 201 CLM videorecordings from phase II cases were randomized and blindly evaluated by two gastroenterologists.
Main outcome measure: The primary endpoints were accuracy values in diagnosing HGIN or early carcinoma (EC)on a per-biopsy basis. Secondary endpoints included interobserver agreement.
Results: All initially defined miniprobe CLM criteria (phase I) were significantly more frequently detected in HGIN/EC sites compared with sites with no or low grade neoplasia (phase II). In a per-biopsy analysis, sensitivity and specificity for two independent investigators were 75% and 80%, and 89% and 94%, respectively, translating at best into a positive predictive value of 44.4% but a negative predictive value of 98.8%. Interobserver agreement was good (kappa 0.6).
Conclusion: Miniprobe CLM showed a high negative predictive value for the diagnosis of endoscopically invisible neoplasia in BE; sensitivity however has still to be improved.