Hepatocellular CarcinomaNCT04163627
Changing Trends in HCC Procedures
An observational study of Hepatocellular Carcinoma, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2019to 25 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with hepatocellular carcinoma with a technical procedure for the treatment of HCC: liver transplantation, liver resection, thermal ablation, chemoembolization or radioembolization
Who may be able to join
- 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
Who cannot join
- Age under 18
- Histological type different of HCC
- Systemic/oral or palliative treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
BORIS GUIU, PU-PH, 467337546 ext. 33, b-guiu@chu-montpellier.fr
Christophe Cassinotto, MD, PhD, 467337380 ext. 33, c-cassinotto@chu-montpellier.fr
About this study
Official title: Epidemiology of Technical Procedures for the Treatment of Hepatocellular Carcinoma: Country-wide Trends From 2009 to 2019
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.
Read the detailed description
Design Observational retrospective epidemiological nationwide cohort
Data source Data will be obtained from the French Programme for the Medicalisation of Information Systems (PMSI) database, which contains all discharge abstracts from all hospitals nationwide. The PMSI includes data on all hospital activities, whether acute (Medecine chirurgiae Obstetrique [MCO]), chronic (Soins de Suite et de Réadaptation [SSR]), or home-care (Hospitalization à Domicile [HAD]). Discharge abstracts include information on the patient's demographics, principal and associated diagnosis codes according to the tenth revision of the International Classification of Diseases (ICD-10) [10], procedure codes, mode of hospitalization (elective, emergency, or hospital transfer), mode of discharge (home, hospital transfer, death; the latter was used to compute survival), duration of hospital stay, patient's home address, and hospital identification code. In addition, each patient has an anonymous alphanumerical identifier that enables all hospital admissions throughout the country to be traced. The databases will be provided for the calendar years 2009 to 2018 included.
Data extraction
- date: 01/01/2009 to 31/12/2018
- ICD-10 diagnostic code: C22.0 (liver cell carcinoma - HCC or hepatoma) and C22.9 (malignant neoplasm of liver, unspecified)
- Patient: age, gender, co-morbidities, postal code
- Cause of chronic liver disease, presence of cirrhosis and severity
- 1st diagnosis of HCC or recurrence
- Hospital of care, status and postal code
- Number and type of therapeutic procedures performed per year (each procedure will be counted according to whether it is the first treatment of HCC or the treatment of a recurrence):
- Liver transplantation
- Destruction of hepatic tumor by radiofrequency, percutaneous
- Destruction of hepatic tumor by radiofrequency, intraoperatively
- Hepatectomy and liver resection:
- Preoperative portal embolization
- Liver arterial chemo-embolization:
- Yttrium 90 Radio Embolization
- Survival from diagnosis and 1st treatment
The expected results of this study are of major importance. On the one hand, this study will provide an overview of the current situation regarding the management of HCC at a national level, by analysing the evolutionary trends of the various therapeutic solutions. The analysis of the geographical variability of care that may exist between different health structures at different levels of expertise, but also at regional or departmental level, is of major importance in order to detect and explain possible differences in terms of prognosis. These data may be of great interest to health authorities or to potential future investigators who will be committed to conducting new prospective projects based on solid and up-to-date data.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Technical procedure for treatment of HCC: either liver transplantation, liver resection, thermal ablation, chemoembolization, or radioembolization, Chronic liver diseases, Interventional Radiology, Liver surgery
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Regional disparities
look for possible regional disparities according to prognosis and access to innovative care
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start30 Nov 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion25 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORIS GUIU, PU-PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163627
- Sponsor's protocol ID
- RECHMPL19_0505
- Status last verified
- Mar 2020
- First submitted
- 13 Nov 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
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.
PubMed 33582392
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Technical Procedures for the Treatment of Hepatocellular Carcinoma: Country-wide Trends From 2009 to 2019
- ClinicalTrials.gov ID
- NCT04163627
- Acronym / sponsor ID
- RECHMPL19_0505
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Technical procedure for treatment of HCC: either liver transplantation, liver resection, thermal ablation, chemoembolization, or radioembolization, Chronic liver diseases, Interventional Radiology, Liver surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 25 Mar 2021 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design Observational retrospective epidemiological nationwide cohort
Data source Data will be obtained from the French Programme for the Medicalisation of Information Systems (PMSI) database, which contains all discharge abstracts from all hospitals nationwide. The PMSI includes data on all hospital activities, whether acute (Medecine chirurgiae Obstetrique [MCO]), chronic (Soins de Suite et de Réadaptation [SSR]), or home-care (Hospitalization à Domicile [HAD]). Discharge abstracts include information on the patient's demographics, principal and associated diagnosis codes according to the tenth revision of the International Classification of Diseases (ICD-10) [10], procedure codes, mode of hospitalization (elective, emergency, or hospital transfer), mode of discharge (home, hospital transfer, death; the latter was used to compute survival), duration of hospital stay, patient's home address, and hospital identification code. In addition, each patient has an anonymous alphanumerical identifier that enables all hospital admissions throughout the country to be traced. The databases will be provided for the calendar years 2009 to 2018 included.
Data extraction
- date: 01/01/2009 to 31/12/2018
- ICD-10 diagnostic code: C22.0 (liver cell carcinoma - HCC or hepatoma) and C22.9 (malignant neoplasm of liver, unspecified)
- Patient: age, gender, co-morbidities, postal code
- Cause of chronic liver disease, presence of cirrhosis and severity
- 1st diagnosis of HCC or recurrence
- Hospital of care, status and postal code
- Number and type of therapeutic procedures performed per year (each procedure will be counted according to whether it is the first treatment of HCC or the treatment of a recurrence):
- Liver transplantation
- Destruction of hepatic tumor by radiofrequency, percutaneous
- Destruction of hepatic tumor by radiofrequency, intraoperatively
- Hepatectomy and liver resection:
- Preoperative portal embolization
- Liver arterial chemo-embolization:
- Yttrium 90 Radio Embolization
- Survival from diagnosis and 1st treatment
The expected results of this study are of major importance. On the one hand, this study will provide an overview of the current situation regarding the management of HCC at a national level, by analysing the evolutionary trends of the various therapeutic solutions. The analysis of the geographical variability of care that may exist between different health structures at different levels of expertise, but also at regional or departmental level, is of major importance in order to detect and explain possible differences in terms of prognosis. These data may be of great interest to health authorities or to potential future investigators who will be committed to conducting new prospective projects based on solid and up-to-date data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with hepatocellular carcinoma with a technical procedure for the treatment of HCC: liver transplantation, liver resection, thermal ablation, chemoembolization or radioembolization
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age under 18
- Histological type different of HCC
- Systemic/oral or palliative treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical procedures evolutiveness
Time frame: 1 day
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 secondary outcome
Regional disparities
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 33582392Cassinotto 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.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BORIS GUIU, PU-PH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BORIS GUIU, PU-PH (467337546 ext. 33, b-guiu@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical procedures evolutiveness (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04163627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.