Multidisciplinary Management of HCC in Elderly Patients

Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; HCC
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00161
    • Department of Surgery "Pietro Valdoni"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients submitted to surgery for HCC nodules resection between 2002 and 2017

Description

Inclusion Criteria:

• HCC patient
• eligible for surgery

Exclusion Criteria:

• non eligible for surgery at first HCC diagnosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: March 10, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; HCC; TACE; Liver resection; HCC in elderly; recurrent HCC; intervention radiology; RF
• Other Study ID Numbers: HEP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No