Clinical trial NCT03807947: Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
Official title: Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-resectable
Keywords: embolisation, therapeutic
Embolization, Therapeutic
Hepatocellular Carcinoma
HCC
TAE
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
3. access-related adverse events
4. 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:

1. the success rates of TRA and TFA including crossing over events between techniques
2. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization
3. access-related adverse events
4. patient preference and reported discomfort

Eligibility criteria: Inclusion criteria:

* patients affected by HCC with indication to TAE from a multidisciplinary team discussion.

Exclusion criteria

* TAE for other malignancies or bleedings;
* Pregnancy.

Primary outcomes:
measure: Pain and discomfort during and after procedures
timeFrame: 24 hours after intervention
Secondary outcomes:
measure: Access-related adverse events
timeFrame: 0-48h after intervention.
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Lombardia
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: EZIO LANZA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.