NCT05243082招募中不适用
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Age above 18
- •EUS fine needle biopsy (FNB) proven pancreatic neuroendocrine tumor (PNET), WHO 2019 Grade 1-2 in patients with functioning or non-functioning tumors. Also
- •MEN1 patients are eligible:
- •PNET 2-3 cm in largest diameter (Based on MRI or CT) with a Ki-67 <5%, or:
- •PNET < 2cm with Ki-67 <10% that has shown progression during surveillance, or:
- •PNET 1.5-2 cm with Ki-67 <10% in patients age < 60 years of age, whether progression is detected or not.
- •Distance from the main pancreatic duct ≥2 mm, or <2mm with a prophylactic stent in the main pancreatic duct.
- •Patient in good general condition, ECOG performance status 0-2 (see Appendix)
- •Signed written informed consent
排除标准
- •Pregnancy.
- •Life expectancy < 1 year
- •Severe hemostasis disorders
- •Pancreatic and/or biliary ductal dilation
- •Evidence of active pancreatitis
- •Metastatic disease, including local lymph node metastases
- •Use of anticoagulants that cannot be discontinued
- •INR >1.5 or platelet count <50.00
- •Distance from the main pancreatic duct <1 mm, and placement of a pancreatic stent is not possible
- •Patient being managed for another malignant lesion which is progressive or under treatment
结局指标
主要结局
Adverse events
时间窗: Up to 12 months
To register number of patient experiencing adverse events to the radiofrequency ablation procedure
Residual disease
时间窗: Up to 5 years
To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation
Metastatic disease
时间窗: Up to 10 years
To register number of patient who develop of local or distant metastases
次要结局
未报告次要终点
研究者
Espen Thiis-Evensen
Senior consultant, MD, PhD
Oslo University Hospital
研究点 (1)
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