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Multidisciplinary Management of HCC in Elderly Patients

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ClinicalTrials.gov Identifier: NCT03875417
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Stefania Brozzetti, Azienda Policlinico Umberto I

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
HCC Quality of Life 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).


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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 : January 1, 2018
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : October 31, 2018

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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients submitted to surgery for HCC nodules resection between 2002 and 2017
Criteria

Inclusion Criteria:

  • HCC patient
  • eligible for surgery

Exclusion Criteria:

  • non eligible for surgery at first HCC diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875417


Locations
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Italy
Department of Surgery "Pietro Valdoni"
Roma, Italy, 00161
Sponsors and Collaborators
Azienda Policlinico Umberto I
Investigators
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Principal Investigator: Stefania Brozzetti, Professor Policlinico Umberto I - Sapienza università di Roma

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Responsible Party: Professor Stefania Brozzetti, Associate Professor, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT03875417     History of Changes
Other Study ID Numbers: HEP001
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor Stefania Brozzetti, Azienda Policlinico Umberto I:
HCC
HCC in elderly
recurrent HCC
Liver resection
Quality of Life
intervention radiology
RF
TACE