Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Carcinological efficacy of pancreatic radiofrequency
研究概览
简要总结
The purpose of the study is to evaluate the oncological efficacy of pancreatic radiofrequency by the objective response rate (complete and partial responses according to RECIST 1.1.), 5 years after the end of treatment.
详细描述
This is a prospective, longitudinal, open, non-randomized, non-interventional, multicenter study on ultrasound-guided radiofrequency endoscopy for the treatment of pancreatic tumours. The study will be offered prospectively to all patients in need of treatment. They will be taken care of in accordance with current practice.
The patient will be seen again 7 times after the end of the pancreatic radiofrequency (which will include one or two sessions): the follow-ups will be done according to current practice on D15 ± 7 days, M6 ± 14 days, M12 ± 1 month then annually until M60 ± 1 month.
The study consists to evaluate the oncological efficacy at 5 years of pancreatic radiofrequency delivered by means of a needle guided by ultrasound endoscopy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Patient to be treated for a pancreatic tumor by ultrasound-guided RF with a fine needle;
- •Indication of pancreatic radiofrequency validated in a Multidisciplinary Consultation Meeting;
- •Patient able to understand the information related to the study;
- •Patient accepting study follow-up visits;
- •Patient having been informed and agreeing to participate in the study.
排除标准
- •Patient with a contraindication to radiofrequency treatment;
- •Pregnant or breastfeeding women
结局指标
主要结局
Carcinological efficacy of pancreatic radiofrequency
时间窗: 5 years
The primary endpoint of the study is the oncological efficacy of pancreatic radiofrequency, which will be assessed by the objective response rate (complete and partial responses according to RECIST 1.1.), 5 years after treatment.
次要结局
未报告次要终点