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临床试验/jRCTs062240133
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

发起方
未提供

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