jRCTs062240133招募中不适用
Efficacy and Safety of EUS-guided radiofrequency ablation for hepaticopancreatic neoplasms
未提供0 个研究点目标入组 20 人开始时间: 2025年4月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit(—)
- 性别
- All
入选标准
- •1 Individuals aged 18 years or older at the time of consent acquisition.
- •2 Individuals who have provided written consent based on their own free will after receiving sufficient explanation and fully understanding the details of the study.
- •3 The pancreatic tumor planned for treatment must be confirmed by pathological examination as one of the following:
- •NEN with Grade 1(WHO2017 classification), or Solid Pseudopapillary Neoplasm(SPN).
- •Note. A pathological examination is not required for liver tumors if blood tests and imaging findings are typical of
- •hepatocellular carcinoma(HCC).
- •4 Tumor diameter must be within 20 mm, as confirmed by contrast enhanced CT.
- •5 For functional NEN, the tumor must be an insulinoma.
排除标准
- •1 History of allergy to contrast agents (iodine).
- •2 Presence of a cardiac pacemaker.
- •3 Distance to the main pancreatic duct is less than 2 mm on imaging (for pancreatic tumors).
- •4 Lymph node metastasis or distant organ metastasis suspected outside the treatment area on imaging.
- •5 Coagulation factor PT (prothrombin time) of 50% or less, or an INR (international normalized ratio) of 1.5 or higher.
- •6 Platelet count of 50.000 per microliter or less.
- •7 Creatinine clearance (eGFR) of less than 30 mL/min/1.73m
- •8 Oral administration of two or more antithrombotic drugs.
- •9 ECOG Performance Status (PS) of 2 to
- •10 Child Pugh classification of C (for liver tumors).
- •11 Cases where treatment is possible with a percutaneous approach (for liver tumors).
- •12 Pregnancy or the possibility of being pregnant.
- •13 Other patients deemed unsuitable for the study by the principal investigator or coinvestigators.
结局指标
主要结局
-
Proportion of complete tumor ablation (at 1 and 6 months)
次要结局
- Disappearance of hypoglycemic symptoms
研究者
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