Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Treatment response
研究概览
简要总结
Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing for patients. To date, only a few small studies have evaluated this treatment and the results are encouraging. It appears necessary to consider a large-scale study to ensure the efficacy and low morbidity of pancreatic RFA applied to PNETs.
详细描述
The primary objective of the study is to evaluate the efficacy of radiofrequency treatment of grade 1 NF-PNETS with a size less than or equal to 2cm.
Patients meeting the selection criteria will be included in the study after signing the consent. They will benefit from a RFA treatment consisting of 1 to 3 sessions depending on their response to the treatment. Patients will then be followed for 5 years in order to evaluate their response to treatment, their clinical evolution, their quality of life and any complications.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreatic mass of less than 2cm on MRI, or CT scan if contraindicated by MRI;
- •Diagnosis of neuroendocrine tumor on biopsy under high echo-endoscopy (HEE) with Ki67<3%,
- •Non-secretory lesion.
- •Homogeneous HEE contrast taking;
- •No positron emission tomography (PET) FDG binding to the pancreatic mass;
- •Lesion <20mm on conventional imaging at 6 months monitoring;
- •Age 18 to 80 years inclusive;
- •Patient in good general condition, World Health Organization [0-1];
- •Signed consent to participate;
- •Affiliation to healthcare insurance system or beneficiary of this regimen.
排除标准
- •Pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;
- •A person in an emergency situation or deprived of liberty or placed under the authority of a tutor.
- •Life expectancy < 1 year;
- •Severe hemostasis disorders;
- •Pancreatic and/or biliary ductal dilation;
- •Lesion considered to be adjacent to the pancreatic duct and/or bile duct;
- •Node extension and/or metastatic disease;
- •Patient being managed for another malignant lesion which is progressive or under treatment.
结局指标
主要结局
Treatment response
时间窗: 1 year
Complete response rate to radiofrequency treatment defined by the absence of enhancement with the contrast agent and/or the disappearance of the lesion on imaging.
次要结局
未报告次要终点