The Tissue Systems Pathology Test Guides Physician Recommendations for Patients With Non-Dysplastic Barrett’s Esophagus: A Case Series From a Gastrointestinal Surgery Center

Abstract

Background: Management strategies that rely on clinicopathologic factors have limited ability in risk-stratifying patients with Barrett’s esophagus (BE). The tissue systems pathology test (TissueCypher, TSP-9) is clinically validated to risk stratify patients with BE for progression to high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC). This study evaluated how TSP-9 results guide clinical management decisions for patients with non-dysplastic BE (NDBE). Methods: TSP-9 results, clinicopathologic data, and clinical management decisions were retrospectively abstracted from health records of 30 patients with NDBE. Management decision data was also collected from treating physicians. TSP-9 reports a risk score (0-10), risk class (low, intermediate, high), and probability of progression to HGD/EAC within 5 years. TSP-9’s utility was analyzed by comparing clinical management decisions before and after receiving test results. Results: TSP-9 scored 25 patients as low-risk, 3 as intermediate-risk, and 2 as high-risk. Physicians changed management decisions for 27 patients (90%) after receiving TSP-9 results, resulting in escalation to shorter-interval surveillance or EET recommendation for six patients (20%) and de-escalation to extend surveillance intervals or recommend no EET for 21 patients (70%). There was significant association between management decisions and TSP-9 results ( P < .001). Management plans aligned with TSP-9 results for 80% of patients, and results impacted management or increased physicians’ reported confidence in management for 97% of patients. Conclusions: TSP-9 provided clinically actionable information for patients with NDBE resulting in management escalation for patients at intermediate/high risk and de-escalation for low risk. TSP-9 can guide risk-aligned management to improve health outcomes for patients with BE.