跳至主要内容
临床试验/NCT05714124
NCT05714124招募中不适用

Liver Embolization Approaches for Tumor Management - Retrospective and Prospective Analysis of the Short-, Medium-, and Long-term Clinical Course of Patients Subjected to Embolization Treatment for Primary and Secondary Liver Neoplasms

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 580 人开始时间: 2021年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
580
试验地点
1
主要终点
Progression free survival

研究概览

简要总结

The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with patients with primary or secondary liver disease not amenable for surgery or ablation
  • patients with primary or secondary liver tumors candidates for major surgery prior to induction of hypertrophy
  • able and willing to sign informed consent

排除标准

  • pregnant women
  • patients with uncorrectable coagulopathy
  • diffuse extrahepatic disease
  • for lobar TACE and TARE - presence of bilodigestive shunt
  • for TARE - >20% hepatopulmonary shunt

结局指标

主要结局

Progression free survival

时间窗: From time of intervention up to 5 years (Long term)

Residual hepatic volume

时间窗: within 40 days of procedure

Treatment Efficacy

次要结局

  • Overall survival(From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco De Cobelli

Head of Radiology

IRCCS San Raffaele

研究点 (1)

Loading locations...

相似试验