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OpenTrials
Completed

NCT Number: NCT03875417

Multidisciplinary Management of HCC in Elderly Patients

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

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Key information

Conditions

HCC Quality of Life

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery "Pietro Valdoni"

Roma, 00161, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HCC patient
  • eligible for surgery

Exclusion criteria

  • non eligible for surgery at first HCC diagnosis

Treatment and study plan

liver resection

Procedure

resection of one or more HCC nodules within the liver

Thermic ablation

Procedure

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

Other names: RF (radiofrequency ablation) / MWA (microwaves ablation)

Transcatheter arterial chemoembolization

Procedure

embolization of HCC nodule via drug-eluted microbeads.

Primary outcomes

  1. Overall survival

    Time frame: follow up time 1-16 years

    survival in months

  2. Disease free survival

    Time frame: follow up time 1-16 years

    survival without recurrences in months

Secondary outcomes

  1. Karnofsky performance scale

    Time frame: follow up time 1-16 years

    evaluation of performance status in dimensionless scale 0 - 100

  2. Activity of Daily living

    Time frame: follow up time 1-16 years

    assess the ability to manage common routine activities evaluated in dimensionless scale 1-6

  3. Instrumental Activity of Daily living

    Time frame: follow up time 1-16 years

    assess the ability to use common instruments evaluated in dimensionless scale 1-8

  4. Blood Haemoglobin

    Time frame: follow up time 1-16 years

    evaluation of mean haemoglobin levels in g/dl

  5. serum Albumin

    Time frame: follow up time 1-16 years

    evaluation of mean albumin levels in g/dl

  6. Geriatric Depression Scale

    Time frame: follow up time 1-16 years

    evaluation of depression in patients in dimensionless scale 0 - 15

Sponsors and collaborators

Lead sponsor

Azienda Policlinico Umberto I

Other

Registry information

Official study title

Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2019
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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