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Multidisciplinary Management of HCC in Elderly Patients

Sponsor
Azienda Policlinico Umberto I (Other)
Overall Status
Completed
CT.gov ID
NCT03875417
Collaborator
(none)
126
Enrollment
1
Location
10
Actual Duration (Months)
12.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: liver resection
  • Procedure: Thermic ablation
  • Procedure: Transcatheter arterial chemoembolization

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).

Study Design

Study Type:
Observational
Actual Enrollment :
126 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
May 30, 2018
Actual Study Completion Date :
Oct 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Group A

Patients who developed HCC recurrences after surgery and treated with re-resection, or microinvasive non-surgical means.

Procedure: liver resection
resection of one or more HCC nodules within the liver

Procedure: Thermic ablation
ablation of HCC nodule through a percutaneous needle, by using radiofrequency or microwaves
Other Names:
  • RF (radiofrequency ablation) / MWA (microwaves ablation)

    • Procedure: Transcatheter arterial chemoembolization
    embolization of HCC nodule via drug-eluted microbeads.
    Group B

    Patients who did not develop recurrences after surgery.

    Procedure: liver resection
    resection of one or more HCC nodules within the liver

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [follow up time 1-16 years]

      survival in months

    2. Disease free survival [follow up time 1-16 years]

      survival without recurrences in months

    Secondary Outcome Measures

    1. Karnofsky performance scale [follow up time 1-16 years]

      evaluation of performance status in dimensionless scale 0 - 100

    2. Activity of Daily living [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 [follow up time 1-16 years]

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

    4. Blood Haemoglobin [follow up time 1-16 years]

      evaluation of mean haemoglobin levels in g/dl

    5. serum Albumin [follow up time 1-16 years]

      evaluation of mean albumin levels in g/dl

    6. Geriatric Depression Scale [follow up time 1-16 years]

      evaluation of depression in patients in dimensionless scale 0 - 15

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • HCC patient

    • eligible for surgery

    Exclusion Criteria:
    • non eligible for surgery at first HCC diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Surgery "Pietro Valdoni" Roma Italy 00161

    Sponsors and Collaborators

    • Azienda Policlinico Umberto I

    Investigators

    • Principal Investigator: Stefania Brozzetti, Professor, Policlinico Umberto I - Sapienza università di Roma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Stefania Brozzetti, Associate Professor, Azienda Policlinico Umberto I
    ClinicalTrials.gov Identifier:
    NCT03875417
    Other Study ID Numbers:
    • HEP001
    First Posted:
    Mar 14, 2019
    Last Update Posted:
    Mar 14, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Professor Stefania Brozzetti, Associate Professor, Azienda Policlinico Umberto I
    HCC
    HCC in elderly
    recurrent HCC
    Liver resection
    Quality of Life
    intervention radiology
    RF
    TACE

    Study Results

    No Results Posted as of Mar 14, 2019