Wide Area Transepithelial Sampling with Computer Assisted Analysis (WATS3D) to detect High Grade Dysplasia and Cancer in Barrett's esophagus: A Multi-Center, Randomized Study

Background and aims Current surveillance for Barrett's esophagus (BE), consisting of 4-quadrant random forceps biopsy (FB), has an inherent risk of sampling error. Wide-Area Transepithelial Sampling (WATS) may increase detection of high-grade dysplasia (HGD) and adenocarcinoma (EAC). In this multicenter, randomized trial, we aimed to evaluate WATS as a substitute for FB. Methods Patients with known BE and a recent history of dysplasia, without visible lesions, at 17 hospitals were randomized to receive either WATS followed by FB or vice-versa. All WATs samples were examined, with computer assistance, by at least two experienced pathologists at the CDx Laboratory. Similarly, all FBs were examined by two expert pathologists. The primary endpoint was concordance/disconcordance for detection of HGD/EAC between both techniques. Results 172 patients were included. Of these, 21 had HGD/EAC detected with both modalities, 18 other had HGD/EAC detected by WATS, but missed with FB and 12 were detected by FB but missed by WATS. The detection rate of HGD/EAC did not differ between WATS and FB (p=0.36). Utilizing WATS as an adjunct to FB significantly increased detection of HGD/EAC vs FB alone (absolute increase 10% [95%-CI: 6-16%]). Mean procedural times in minutes for FB alone, WATS alone, and the combination were 6.6 (95% CI:5.9-7.1), 4.9 (95% CI:4.1-5.4), and 11.2 (95%-CI:10.5-14.0) respectively. Conclusions Although the combination of WATS and FB increases dysplasia detection in a population of BE patients enriched for dysplasia, we did not find a statistically significant difference between WATS and FB for detection of HGD/EAC as single modality.