跳至主要内容
临床试验/NL-OMON55994
NL-OMON55994招募中不适用

PROspective Multi-center study to Evaluate the correlation between safety margin and local recurrence after THErmal ablation USing image co-registration in patients with hepatocellular carcinoma (PROMETHEUS-study) - PROMETHEUS

eids Universitair Medisch Centrum0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • In order to be eligible to participate in this study, a subject must meet all
  • of the following criteria:
  • - Age 18 yrs or above
  • - HCC very early (0) or early stage (A) according to the BCLC staging system OR
  • HCC intermediate stage (B) with a maximum of two lesions of <=5cm each
  • - Either de novo or recurrent HCC (prior locoregional therapy is allowed in the
  • - Candidate for percutaneous thermal ablation as discussed in a
  • multidisciplinary tumor board
  • - Absence of any psychological, familial, sociological or geographical
  • condition potentially hampering compliance with the study protocol and
  • follow-up schedule
  • - Written informed consent

排除标准

  • A potential subject who meets any of the following criteria will be excluded
  • from participation in this study:
  • - Estimated GFR <30 ml/min
  • - Known severe allergy to contrast medium
  • - ASA classification higher than 3
  • - Child Pugh C
  • - ECOG >=1 (tumor-related)
  • - Portal vein tumor invasion
  • - Extrahepatic metastasis
  • - Neoadjuvant transarterial therapy (TACE, TAE or TARE), i.e. combination
  • therapy of transarterial therapy with ablation
  • - Uncorrectable coagulopathy

研究者

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