NCT03875417

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

March 10, 2019

Last Update Submit

March 12, 2019

Conditions

HCCQuality of Life

Keywords

HCCHCC in elderlyrecurrent HCCLiver resectionQuality of Lifeintervention radiologyRFTACE

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Karnofsky performance scale

    follow up time 1-16 years

  • Activity of Daily living

    follow up time 1-16 years

  • Instrumental Activity of Daily living

    follow up time 1-16 years

  • Blood Haemoglobin

    follow up time 1-16 years

  • serum Albumin

    follow up time 1-16 years

  • +1 more secondary outcomes

Study Arms (2)

Group A

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

Procedure: liver resectionProcedure: Thermic ablationProcedure: Transcatheter arterial chemoembolization

Group B

Patients who did not develop recurrences after surgery.

Procedure: liver resection

Interventions

liver resectionPROCEDURE

resection of one or more HCC nodules within the liver

Group AGroup B
Thermic ablationPROCEDURE

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

Also known as: RF (radiofrequency ablation) / MWA (microwaves ablation)
Group A
Transcatheter arterial chemoembolizationPROCEDURE

embolization of HCC nodule via drug-eluted microbeads.

Group A

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • HCC patient
  • eligible for surgery

You may not qualify if:

  • non eligible for surgery at first HCC diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery "Pietro Valdoni"

Roma, 00161, Italy

Location

MeSH Terms

Interventions

HepatectomyRadiofrequency Ablation

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeRadiofrequency TherapyTherapeuticsAblation Techniques

Study Officials

  • Stefania Brozzetti, Professor

    Policlinico Umberto I - Sapienza università di Roma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 14, 2019

Study Start

January 1, 2018

Primary Completion

May 30, 2018

Study Completion

October 31, 2018

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)