A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients.
详细描述
A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients. The study also includes a feasibility study to evaluate the role of intraoperative nCLE in the diagnosis and staging of pancreatic tumours. This part of the study will recruit a further 20 patients.
Primary endpoint:
Assess the diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts, compared to standard diagnostic modalities.
Secondary endpoints:
- Assess the safety and efficacy of EUS-nCLE.
- Assess the impact of the Cellvizio nCLE system on the management of patients with pancreatic cysts.
- Develop and validate interpretation criteria for nCLE in the pancreas.
- Assess the diagnostic performance of nCLE in characterising and staging pancreatic tumours intraoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging for which EUS-FNA is indicated.
- •Pancreatic cystic tumour >1cm in size.
- •ECOG performance status 0, 1 or
- •Estimated life expectancy of at least 12 weeks.
- •Age >18 years.
- •Capable of giving written informed consent.
- •Has not has pancreatitis within the previous 3 months.
- •Women of child-bearing potential must have a negative pregnancy test in the week before nCLE, AND be using an adequate contraception method, which must be continued for at least 1 week after nCLE.
排除标准
- •Acute pancreatitis in the last 3 months.
- •Subject with multiple cysts
- •Subjects for whom EUS-FNA or surgery are contraindicated
- •Known allergy to fluorescein dye
- •Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
- •Any psychiatric disorder making reliable informed consent impossible.
- •Pregnancy or breast-feeding.
- •ECOG performance status 3 or 4
结局指标
主要结局
Diagnostic accuracy
时间窗: 3 years
Assess the diagnostic accuracy of the Cellvizio nCLE system for diagnosing cystic lesions of the pancreas, compared to standard diagnostic modalities
次要结局
- Adverse events(3 years)
- Interpretation criteria(3 years)
- Assess margins(3 years)