Foley Kieran G, Boxall Cherish, Franklin James, Cook Andrew, Underwood Tim, Griffiths Gareth, Cozens Kelly, Bradbury Katherine, Fay Margaret, Chuter David, Longman Kerry-Ann, Lindfield Ben, Hurt Chris
Division of Cancer & Genetics, School of Medicine, Cardiff University, Cardiff, CF14 4XN, United Kingdom.
Cancer Research UK Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, SO16 6YD, United Kingdom.
BJR Open. 2025 May 21;7(1):tzaf012. doi: 10.1093/bjro/tzaf012. eCollection 2025 Jan.
OBJECTIVES: Over 9000 patients are diagnosed with oesophageal cancer annually in the United Kingdom (UK). Decision-making about treatment options is influenced by radiological staging, which may include computed tomography (CT), positron emission tomography (PET), and endoscopic ultrasound (EUS). The use of EUS varies considerably around the UK and, since the introduction of PET-CT, the added value of EUS has been questioned. The VALUE study aims to understand this variation and determine how often and why EUS changes treatment decisions. VALUE will also evaluate patient and clinician experiences and opinions of EUS. METHODS: This is a prospective, observational study investigating EUS in oesophageal cancer staging. Patients will be recruited at up to eleven sites in the UK, where they will be consented (if eligible) and registered onto iMedidata RAVE. Clinical and demographic data, TNM staging, pre and post EUS treatment decisions, and complications will be collected. We will attempt to sample patients from ethnic minority backgrounds in the study population, as they are underrepresented in research. Up to 30 patients and 30 clinicians will be interviewed to evaluate the use of EUS and experiences of both patient and clinician. The primary endpoint is the proportion of cases that EUS changes treatment decisions. Secondary endpoints include identification of factors that clinicians' and patients consider when deciding if EUS should be used, the time from diagnosis to treatment decision before and after EUS, and the reasons why EUS changed management. The study has been registered on Clinicaltrials.gov: NCT06440174. The trial is open to recruitment. RESULTS: In total, 180 patients with potentially curable oesophageal cancer who are suitable for EUS will participate. Recruitment is currently planned until September 2025 and study results will be reported after June 2026. CONCLUSION: The VALUE study will enable a better understanding of how and why EUS is used in oesophageal cancer. This research will identify important factors that clinicians and patients consider when deciding EUS use and determine the frequency that EUS changes treatment decisions in the modern staging pathway. ADVANCES IN KNOWLEDGE: The VALUE study is a prospective, multi-centre observational study investigating the use of EUS in the modern era of oesophageal cancer staging. The study aims to determine how often and why EUS changes treatment decisions. A qualitative component will explore both clinician and patient attitudes towards EUS.
目标：在英国，每年有超过9000例患者被诊断为食管癌。治疗方案的决策受放射学分期影响，放射学分期可能包括计算机断层扫描（CT）、正电子发射断层扫描（PET）和内镜超声检查（EUS）。在英国，EUS的使用差异很大，并且自PET-CT引入以来，EUS的附加值受到质疑。VALUE研究旨在了解这种差异，并确定EUS改变治疗决策的频率及原因。VALUE研究还将评估患者和临床医生对EUS的体验和看法。 方法：这是一项前瞻性观察性研究，调查EUS在食管癌分期中的应用。将在英国多达11个地点招募患者，符合条件者将签署知情同意书并登记到iMedidata RAVE系统。收集临床和人口统计学数据、TNM分期、EUS检查前后的治疗决策以及并发症情况。我们将尝试在研究人群中抽取少数族裔背景的患者，因为他们在研究中的代表性不足。将对多达30名患者和30名临床医生进行访谈，以评估EUS的使用情况以及患者和临床医生的体验。主要终点是EUS改变治疗决策的病例比例。次要终点包括确定临床医生和患者在决定是否使用EUS时考虑的因素、EUS检查前后从诊断到做出治疗决策的时间，以及EUS改变治疗方案的原因。该研究已在Clinicaltrials.gov注册：NCT06440174。该试验正在招募患者。 结果：总共将有180例适合进行EUS检查的潜在可治愈食管癌患者参与研究。目前计划招募至2025年9月，研究结果将于2026年6月之后报告。 结论：VALUE研究将有助于更好地了解EUS在食管癌中如何以及为何被使用。这项研究将确定临床医生和患者在决定是否使用EUS时考虑的重要因素，并确定在现代分期流程中EUS改变治疗决策的频率。 知识进展：VALUE研究是一项前瞻性多中心观察性研究，调查EUS在现代食管癌分期中的应用。该研究旨在确定EUS改变治疗决策的频率及原因。一个定性部分将探讨临床医生和患者对EUS的态度。
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