NCT04163627

Brief Summary

In France, as in most countries, the incidence of primary liver cancer has increased significantly since the 1980s. In the United States, a study estimating cancer incidence and mortality rates in the coming years predicts that primary liver cancer will become the 3rd leading cause of cancer death from 2030 onwards, behind lung and pancreatic cancer, but ahead of colorectal cancer. This increase in incidence could be explained on the one hand by an increase in the incidence of chronic liver diseases, particularly those related to alcohol and metabolic steatopathies in the West, and on the other hand by improved management of the consequences of cirrhotic disease, which in turn increases the time needed for hepatocellular carcinoma (HCC) to form and develop. The management of a patient with hepatocellular carcinoma is complex because of the underlying cirrhotic disease, which hinders the development of many therapies. Thus, the patient's prognosis depends as much on the tumour extension as on the severity of the underlying chronic liver disease, and the choice of appropriate treatment is based on optimizing the balance between maximum antitumor efficacy and limited liver toxicity. It is in this context that minimally invasive technical acts, whether local or local-regional, have developed significantly in recent years. Percutaneous tumor destruction techniques have become highly diversified with the development of microwave ablatherm, multipolar radiofrequency, or irreversible electroporation. For intra-arterial treatments, hepatic arterial chemoembolization remains the reference treatment for BCLC B stages. Alongside it, Yttrium 90 radio-embolization is booming, although its precise place remains to be defined in the therapeutic arsenal. Surgical techniques have also progressed, with the development of laparoscopic resections and improved liver transplant management. Finally, external radiotherapy is a recourse solution that can make it possible to propose a therapeutic solution in selected patients. This multidisciplinary management of the HCC is in constant evolution and improvement, which justifies regularly carrying out an inventory of the frequency of these various technical acts at the national level. The objective of our study is to analyze the evolution, over the last 10 years and at a national level, of the various technical procedures available in the HCC therapeutic arsenal based on data from the french national PMSI database.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

November 30, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

November 13, 2019

Last Update Submit

March 9, 2020

Conditions

Keywords

Technical procedure for treatment of HCC: either liver transplantation, liver resection, thermal ablation, chemoembolization, or radioembolizationChronic liver diseasesInterventional RadiologyLiver surgery

Outcome Measures

Primary Outcomes (1)

  • Technical procedures evolutiveness

    Quantify at the national level the progression from 2009 to 2019 in the number of procedures performed as part of the treatment of HCC, divided into percutaneous or intraoperative tumour destruction, chemo-embolisation, radio-embolisation, liver surgery and liver transplantation.

    1 day

Secondary Outcomes (1)

  • Regional disparities

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with hepatocellular carcinoma with a technical procedure for the treatment of HCC: liver transplantation, liver resection, thermal ablation, chemoembolization or radioembolization

You may qualify if:

  • An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
  • Aged above 18 years
  • ICD-10 diagnostic code: C22.0 (liver cell carcinoma - HCC or hepatoma) and C22.9 (malignant neoplasm of liver, unspecified)
  • Having had at least one technical procedure for management of an HCC
  • Date of procedure: 01/01/2009 to 31/12/2018

You may not qualify if:

  • Age under 18
  • Histological type different of HCC
  • Systemic/oral or palliative treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

  • Cassinotto C, Nogue E, Morell M, Panaro F, Molinari N, Guiu B. Changing trends in hepatocellular carcinoma management: Results from a nationwide database in the last decade. Eur J Cancer. 2021 Mar;146:48-55. doi: 10.1016/j.ejca.2021.01.009. Epub 2021 Feb 11.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • BORIS GUIU, PU-PH

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

BORIS GUIU, PU-PH

CONTACT

Christophe Cassinotto, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 15, 2019

Study Start

November 30, 2019

Primary Completion

March 1, 2021

Study Completion

March 25, 2021

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations