Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma

NCT03807947 | Unknown

• 1 other identifier: ICHRadialTAE
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatocellular Carcinoma; Hepatocellular Carcinoma Non-resectable

Keywords

embolisation, therapeutic; Embolization, Therapeutic; Hepatocellular Carcinoma; HCC; TAE

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after intervention

Secondary Outcomes (1)

• Access-related adverse events

  0-48h after intervention.

Study Arms (2)

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

Interventions

Radial TAE - Bland embolization with 40-100 Microparticles PROCEDURE

TAE - Bland embolization with 40-100 Microparticles performed via left transradial access

Radial access

Transfemoral TAE - Bland embolization with 40-100 Microparticles PROCEDURE

TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access

Transfemoral Access

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• TAE for other malignancies or bleedings;
• Pregnancy.

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Lombardy, 20089, Italy

Location

Related Publications (1)

• 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.

  PMID: 28757286 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• EZIO LANZA, MD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: January 17, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: April 1, 2020
• Last Updated: January 17, 2019

Record last verified: 2019-01

Locations

IT (1)