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Multidisciplinary Management of HCC in Elderly Patients

Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03875417
Enrollment
126
Registered
2019-03-14
Start date
2018-01-01
Completion date
2018-10-31
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC, Quality of Life

Keywords

HCC, HCC in elderly, recurrent HCC, Liver resection, Quality of Life, intervention radiology, RF, TACE

Brief summary

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

Detailed description

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).

Interventions

PROCEDUREliver resection

resection of one or more HCC nodules within the liver

PROCEDUREThermic ablation

ablation of HCC nodule through a percutaneous needle, by using radiofrequency or microwaves

PROCEDURETranscatheter arterial chemoembolization

embolization of HCC nodule via drug-eluted microbeads.

Sponsors

Azienda Policlinico Umberto I
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HCC patient * eligible for surgery

Exclusion criteria

* non eligible for surgery at first HCC diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Overall survivalfollow up time 1-16 yearssurvival in months
Disease free survivalfollow up time 1-16 yearssurvival without recurrences in months

Secondary

MeasureTime frameDescription
Instrumental Activity of Daily livingfollow up time 1-16 yearsassess the ability to use common instruments evaluated in dimensionless scale 1-8
Blood Haemoglobinfollow up time 1-16 yearsevaluation of mean haemoglobin levels in g/dl
Karnofsky performance scalefollow up time 1-16 yearsevaluation of performance status in dimensionless scale 0 - 100
Geriatric Depression Scalefollow up time 1-16 yearsevaluation of depression in patients in dimensionless scale 0 - 15
serum Albuminfollow up time 1-16 yearsevaluation of mean albumin levels in g/dl
Activity of Daily livingfollow up time 1-16 yearsassess the ability to manage common routine activities evaluated in dimensionless scale 1-6

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026