Hepatocellular CarcinomaNCT03807947
Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
A study testing Radial TAE - Bland embolization with 40-100 Microparticles and Transfemoral TAE - Bland embolization with 40-100 Microparticles in people with Hepatocellular Carcinoma and Hepatocellular Carcinoma Non-resectable, run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial summary
The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators. In particular, main objectives are to compare: 1. the success rates of TRA and TFA including crossing over events between techniques 2. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable
- What is being tested?
- Radial TAE - Bland embolization with 40-100 Microparticles and Transfemoral TAE - Bland embolization with 40-100 Microparticles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2019to Apr 2020
- Phase
- Interventional
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients affected by HCC with indication to TAE from a multidisciplinary team discussion.
Who cannot join
- TAE for other malignancies or bleedings;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators.
In particular, main objectives are to compare:
- the success rates of TRA and TFA including crossing over events between techniques
- the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
- access-related adverse events
- patient preference and reported discomfort
Read the detailed description
Hepatic arterial chemoembolization is a safe, proven, and effective technique for the treatment of a number of malignancies, including primary and secondary tumors [1, 2]. This endovascular treatment is performed via femoral artery access in most cases. In the last decades, the transradial approach (TRA) has emerged as a valid alternative to the transfemoral approach (TFA), and it is commonly used in coronary angioplasty as well as stent placement. In particular, shorter monitoring time after the procedure, earlier ambulation, shorter hospital stay and less discomfort associated with potentially reduced bleeding risks make TRA an attractive alternative to TFA.
To date, only one study exists comparing TRA vs TFA in liver embolizations [3]. However, it is non-randomized and reports only the outcomes of one operator performing lobar embolization for multiple liver malignancies.
The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators.
In particular, main objectives are to compare:
- the success rates of TRA and TFA including crossing over events between techniques
- the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
- access-related adverse events
- patient preference and reported discomfort
- Being tested
- Radial TAE - Bland embolization with 40-100 Microparticles, Transfemoral TAE - Bland embolization with 40-100 Microparticles
- Keywords
- embolisation, therapeutic, Embolization, Therapeutic, Hepatocellular Carcinoma, HCC, TAE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial TAE - Bland embolization with 40-100 MicroparticlesProcedure or surgery
TAE - Bland embolization with 40-100 Microparticles performed via left transradial access
Transfemoral TAE - Bland embolization with 40-100 MicroparticlesProcedure or surgery
TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access
| Study group | Role | What they receive |
|---|---|---|
| Radial access | Experimental | Not described Receives: Procedure: Radial TAE - Bland embolization with 40-100 Microparticles |
| Transfemoral Access | Active comparator | Not described Receives: Procedure: Transfemoral TAE - Bland embolization with 40-100 Microparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and discomfort during and after procedures
Questionnaire with four questions with 5 a points scale describing pain and discomfort during and after procedure, where 0 is the minimum and 4 the maximum.
Measured: 24 hours after intervention
Secondary outcomes (1)
Access-related adverse events
Complication at the site of access like hematoma or pseudoaneurysm
Measured: 0-48h after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EZIO LANZA, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807947
- Sponsor's protocol ID
- ICHRadialTAE
- Status last verified
- Jan 2019
- First submitted
- 25 Dec 2018
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Iezzi R, Pompili M, Posa A, Annicchiarico E, Garcovich M, Merlino B, Rodolfino E, Di Noia V, Basso M, Cassano A, Barone C, Gasbarrini A, Manfredi R, Colosimo C. Transradial versus Transfemoral Access for Hepatic Chemoembolization: Intrapatient Prospective Single-Center Study. J Vasc Interv Radiol. 2017 Sep;28(9):1234-1239. doi: 10.1016/j.jvir.2017.06.022. Epub 2017 Jul 27.
PubMed 28757286
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03807947
- Acronym / sponsor ID
- ICHRadialTAE
- Keywords
- embolisation, therapeutic, Embolization, Therapeutic, Hepatocellular Carcinoma, HCC, TAE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 17 Jan 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.
The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators.
In particular, main objectives are to compare:
- the success rates of TRA and TFA including crossing over events between techniques
- the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
- access-related adverse events
- patient preference and reported discomfort
Detailed description
Hepatic arterial chemoembolization is a safe, proven, and effective technique for the treatment of a number of malignancies, including primary and secondary tumors [1, 2]. This endovascular treatment is performed via femoral artery access in most cases. In the last decades, the transradial approach (TRA) has emerged as a valid alternative to the transfemoral approach (TFA), and it is commonly used in coronary angioplasty as well as stent placement. In particular, shorter monitoring time after the procedure, earlier ambulation, shorter hospital stay and less discomfort associated with potentially reduced bleeding risks make TRA an attractive alternative to TFA.
To date, only one study exists comparing TRA vs TFA in liver embolizations [3]. However, it is non-randomized and reports only the outcomes of one operator performing lobar embolization for multiple liver malignancies.
The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators.
In particular, main objectives are to compare:
- the success rates of TRA and TFA including crossing over events between techniques
- the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
- access-related adverse events
- patient preference and reported discomfort
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial access | Experimental | Procedure: Radial TAE - Bland embolization with 40-100 Microparticles |
| Transfemoral Access | Active comparator | Procedure: Transfemoral TAE - Bland embolization with 40-100 Microparticles |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients affected by HCC with indication to TAE from a multidisciplinary team discussion.
Key exclusion criteria (2 listed)
- TAE for other malignancies or bleedings;
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial TAE - Bland embolization with 40-100 MicroparticlesTAE - Bland embolization with 40-100 Microparticles performed via left transradial access | Procedure or surgery | Radial access |
| Transfemoral TAE - Bland embolization with 40-100 MicroparticlesTAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access | Procedure or surgery | Transfemoral Access |
Primary outcome
Pain and discomfort during and after procedures
Time frame: 24 hours after intervention
Questionnaire with four questions with 5 a points scale describing pain and discomfort during and after procedure, where 0 is the minimum and 4 the maximum.
1 secondary outcome
Access-related adverse events
Time frame: 0-48h after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Background: PubMed 28757286Iezzi R, Pompili M, Posa A, Annicchiarico E, Garcovich M, Merlino B, Rodolfino E, Di Noia V, Basso M, Cassano A, Barone C, Gasbarrini A, Manfredi R, Colosimo C. Transradial versus Transfemoral Access for Hepatic Chemoembolization: Intrapatient Prospective Single-Center Study. J Vasc Interv Radiol. 2017 Sep;28(9):1234-1239. doi: 10.1016/j.jvir.2017.06.022. Epub 2017 Jul 27.
- Individual participant dataSharing planned: Undecided
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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.
EZIO LANZA, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial TAE - Bland embolization with 40-100 Microparticles and Transfemoral TAE - Bland embolization with 40-100 Microparticles in people with Hepatocellular Carcinoma and Hepatocellular Carcinoma Non-resectable, run by Humanitas Clinical and Research Center at 1 site in Italy.
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 1 inclusion and 2 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 17 Jan 2019. 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and discomfort during and after procedures (time frame: 24 hours after intervention). 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 NCT03807947, 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 17 Jan 2019.