Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients with Oesophageal Cancer (VALUE): a Multi-methods Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Number of patients who change treatment management
研究概览
简要总结
This is an observational trial that will look at patients undergoing endoscopic ultrasound (EUS) in patients with oesophageal cancer and to determine the proportion of cases in which EUS changes disease management in these patients.
详细描述
Over 9,000 patients are diagnosed with oesophageal cancer in the United Kingdom (UK) annually. The prognosis of these patients is poor, with an overall 5-year survival rate of 15%.
Most patients (60%) present with advanced disease and palliation is the only treatment option. Accordingly, oesophageal cancer has considerable unmet research need.
The VALUE trial is a prospective observational study investigating EUS in the modern era of oesophageal cancer staging. A quantitative study component will examine how often and why EUS changes treatment decisions after initial staging with CT and PET-CT. A qualitative study component will explore both clinician and patient attitudes and opinions towards the utility of EUS in the staging pathway.
EUS is an invasive procedure combining upper gastrointestinal endoscopy with ultrasonography. An ultrasound probe located at the end of the endoscope allows direct visualisation of the oesophageal wall layers and adjacent tissues providing local assessment of the depth of tumour invasion and lymph nodes. This assessment informs local tumour (T-) and node (N-) staging which are important prognostic indicators of survival. Patients undergoing EUS require sedation and there are risks of complication. EUS is a specialist investigation requiring many years of dedicated training to perform competently.
VALUE aims to recruit patients with oesophageal cancer who are deemed to have potentially curable disease and who are fit for, and wish to have, radical treatment, and who receive EUS as part of their standard of care staging pathway. Patients with a range of disease status (T1-T4; N0-N3) will be considered for recruitment to allow diverse consideration of the reasons whether EUS impacts treatment decisions in current clinical practice. VALUE will also recruit clinicians who regularly care for oesophageal cancer patients in a multi-disciplinary setting to gather their opinions regarding the use of EUS in this patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16 or above with first diagnosis of biopsy-confirmed oesophageal cancer.
- •Referred for EUS examination as part of standard of care investigations.
- •Tumour location in the oesophagus, or gastro-oesophageal junction (Siewert types I-III)
- •MDT decision that patient is potentially curable with radical treatment (e.g., endoscopic treatment, surgery +/- neoadjuvant therapy, or definitive chemoradiotherapy)
- •Prior staging with CT and PET-CT
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Clinical staging of T1-T4, N0-N3, M0 disease
- •Adenocarcinoma or squamous cell carcinoma (SCC) histopathological cell type
排除标准
- •Recurrent or residual disease
- •Distant metastatic disease detected before EUS.
- •Previous oesophagectomy or oesophageal radiotherapy
- •Unable to undergo EUS examination.
- •Concurrent malignancy e.g., second primary tumour
- •Other histopathological cell type
结局指标
主要结局
Number of patients who change treatment management
时间窗: this decision will be made at baseline.
to determine if using EUS after CT-PET changes management.
次要结局
- Number of clinicians and patients who will share their opinions on EUS by a one to one interview with a qualitative researcher.(This will take place up to 6 weeks following the EUS at one to one interviews.)
- Number of patients who changed their treatment management following EUS.(this decision will be made at baseline.)
- Number of patients who decided on their treatment.(this decision will be made at baseline.)