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临床试验/NCT03875417
NCT03875417已完成不适用

Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis

Azienda Policlinico Umberto I1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

详细描述

Introduction- Hepatocellular carcinoma (HCC) is the most common primary liver malignancy. It usually develops in cirrhotic liver with high recurrence rates. More than 2/3 of patients are elderly, often excluded from surgery and follow-up protocols. Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

Materials and methods- 126 patients, aged between 65 and 90 years, submitted to liver resection for HCC were enrolled. They were divided into three classes. Class 1 included patients submitted to major resections, Class 2 to minor resections and Class 3 to minor resections associated with thermoablation. All of them were clinically and radiologically followed up. Patients who developed recurrences (Group A) were referred to further treatments (surgery, interventional radiology or pharmacological therapy). Mortality, disease-free survival (DFS), overall survival (OS) and quality of life (QoL) were evaluated and compared with non-recurrent patients (Group B).

Used interventional radiology means were Radiofrequency ablation (RF), microwaves ablation (MWA) or transcatheter arterial chemoembolization (TACE).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • HCC patient
  • eligible for surgery

排除标准

  • non eligible for surgery at first HCC diagnosis

结局指标

主要结局

Overall survival

时间窗: follow up time 1-16 years

survival in months

Disease free survival

时间窗: follow up time 1-16 years

survival without recurrences in months

次要结局

  • Blood Haemoglobin(follow up time 1-16 years)
  • Activity of Daily living(follow up time 1-16 years)
  • serum Albumin(follow up time 1-16 years)
  • Karnofsky performance scale(follow up time 1-16 years)
  • Geriatric Depression Scale(follow up time 1-16 years)
  • Instrumental Activity of Daily living(follow up time 1-16 years)

研究者

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

Professor Stefania Brozzetti

Associate Professor

Azienda Policlinico Umberto I

研究点 (1)

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