Abstract：
Low-grade dysplasia (LGD) is associated with an increased risk of progression in Barrett\'s esophagus (BE); however, the diagnosis of LGD is limited by substantial interobserver variability. Multiple studies have shown that an objective tissue systems pathology test (TissueCypher Barrett\'s Esophagus Test, TSP-9), can effectively predict neoplastic progression in patients with BE. This study aimed to compare the risk stratification performance of the TSP-9 test vs benchmarks of generalist and expert pathology.
A blinded cohort study was conducted in the screening cohort of a randomized controlled trial of patients with BE with community-based LGD. Biopsies from the first endoscopy with LGD were assessed by the TSP-9 test and independently reviewed by 30 pathologists from 5 countries per standard practice. The accuracy of the test and the diagnoses in predicting high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) were compared.
A total of 154 patients with BE (122 men), mean age 60.9 ± 9.8 years were studied. Twenty-four patients progressed to HGD/EAC within 5 years (median time of 1.7 years) and 130 did not progress to HGD/EAC within 5 years (median 7.8 years follow-up). The TSP-9 test demonstrated higher sensitivity (71% vs mean 63%, range 33%-88% across 30 pathologists), than the pathology review in detecting patients who progressed (P = .01186).
The TSP-9 test outperformed the pathologists in risk stratifying patients with BE with LGD. Care guided by the test can provide an effective solution to variable pathology review of LGD, improving health outcomes by upstaging care to therapeutic intervention for patients at high risk for progression, while reducing unnecessary interventions in low-risk patients.
A blinded cohort study was conducted in the screening cohort of a randomized controlled trial of patients with BE with community-based LGD. Biopsies from the first endoscopy with LGD were assessed by the TSP-9 test and independently reviewed by 30 pathologists from 5 countries per standard practice. The accuracy of the test and the diagnoses in predicting high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) were compared.
A total of 154 patients with BE (122 men), mean age 60.9 ± 9.8 years were studied. Twenty-four patients progressed to HGD/EAC within 5 years (median time of 1.7 years) and 130 did not progress to HGD/EAC within 5 years (median 7.8 years follow-up). The TSP-9 test demonstrated higher sensitivity (71% vs mean 63%, range 33%-88% across 30 pathologists), than the pathology review in detecting patients who progressed (P = .01186).
The TSP-9 test outperformed the pathologists in risk stratifying patients with BE with LGD. Care guided by the test can provide an effective solution to variable pathology review of LGD, improving health outcomes by upstaging care to therapeutic intervention for patients at high risk for progression, while reducing unnecessary interventions in low-risk patients.
摘要：
目的：低度发育不良（LGD）与Barrett食管（BE）进展风险增加相关。然而,LGD的诊断受观察者间差异的限制。多项研究表明，客观的组织系统病理学测试(TissueCypherBarrett食管试验，TSP-9),可以有效预测BE患者的肿瘤进展。本研究旨在比较TSP-9测试与通才和专家病理学基准的风险分层性能。
方法：在一项针对患有社区LGD的BE患者的随机对照试验的筛查队列中进行了一项盲法队列研究。通过TSP-9测试评估了首次使用LGD进行内窥镜检查的活检，并根据标准实践由来自五个国家的30名病理学家进行了独立审查。比较了预测高度异型增生（HGD）和食管腺癌（EAC）的测试和诊断的准确性。
结果：154名BE患者（122名男性），研究平均年龄60.9+/-9.8岁.24例患者在5年内进展到HGD/EAC（中位时间为1.7年），130例患者在5年内未进展到HGD/EAC（中位随访7.8年）。TSP-9测试显示出更高的灵敏度(71%vs.平均63%，30位病理学家的33-88%)，在检测进展的患者中，病理检查优于病理检查（P=0.01186）。
结论：TSP-9检验在对患有LGD的BE患者进行风险分层方面优于病理学家。以试验为指导的护理可以为LGD的可变病理检查提供有效的解决方案，通过将护理升级为治疗性干预，改善疾病进展高风险患者的健康结果，同时减少对低风险患者的不必要干预。
方法：在一项针对患有社区LGD的BE患者的随机对照试验的筛查队列中进行了一项盲法队列研究。通过TSP-9测试评估了首次使用LGD进行内窥镜检查的活检，并根据标准实践由来自五个国家的30名病理学家进行了独立审查。比较了预测高度异型增生（HGD）和食管腺癌（EAC）的测试和诊断的准确性。
结果：154名BE患者（122名男性），研究平均年龄60.9+/-9.8岁.24例患者在5年内进展到HGD/EAC（中位时间为1.7年），130例患者在5年内未进展到HGD/EAC（中位随访7.8年）。TSP-9测试显示出更高的灵敏度(71%vs.平均63%，30位病理学家的33-88%)，在检测进展的患者中，病理检查优于病理检查（P=0.01186）。
结论：TSP-9检验在对患有LGD的BE患者进行风险分层方面优于病理学家。以试验为指导的护理可以为LGD的可变病理检查提供有效的解决方案，通过将护理升级为治疗性干预，改善疾病进展高风险患者的健康结果，同时减少对低风险患者的不必要干预。
