Multidisciplinary Management of HCC in Elderly Patients

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

Detailed Description
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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).

Official Title
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Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis

Conditions
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HCC, Quality of Life

Intervention / Treatment
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* Procedure: liver resection
* Procedure: Thermic ablation
* Procedure: Transcatheter arterial chemoembolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCC patient eligible for surgery Exclusion Criteria: non eligible for surgery at first HCC diagnosis

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Patients who developed HCC recurrences after surgery and treated with re-resection, or microinvasive non-surgical means. | Procedure: liver resection<br>* resection of one or more HCC nodules within the liver<br>Procedure: Thermic ablation<br>* ablation of HCC nodule through a percutaneous needle, by using radiofrequency or microwaves<br>* Other names: RF (radiofrequency ablation) / MWA (microwaves ablation);Procedure: Transcatheter arterial chemoembolization<br>* embolization of HCC nodule via drug-eluted microbeads.<br>|
| Group B<br>Patients who did not develop recurrences after surgery. | Procedure: liver resection<br>* resection of one or more HCC nodules within the liver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | survival in months | follow up time 1-16 years | 
| Disease free survival | survival without recurrences in months | follow up time 1-16 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karnofsky performance scale | evaluation of performance status in dimensionless scale 0 - 100 | follow up time 1-16 years | 
| Activity of Daily living | assess the ability to manage common routine activities evaluated in dimensionless scale 1-6 | follow up time 1-16 years | 
| Instrumental Activity of Daily living | assess the ability to use common instruments evaluated in dimensionless scale 1-8 | follow up time 1-16 years | 
| Blood Haemoglobin | evaluation of mean haemoglobin levels in g/dl | follow up time 1-16 years | 
| serum Albumin | evaluation of mean albumin levels in g/dl | follow up time 1-16 years | 
| Geriatric Depression Scale | evaluation of depression in patients in dimensionless scale 0 - 15 | follow up time 1-16 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, HCC in elderly, recurrent HCC, Liver resection, Quality of Life, intervention radiology, RF, TACE