Transradial Versus Transfemoral Arterial Access in Liver Cancer Embolization: Randomized Trial to Assess Patient Outcomes and Satisfaction (BEST ACCESS Trial).

NCT03163186 | Completed DMC

• 1 other identifier: PRO33987
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, advantages, and appropriateness of performing transarterial hepatic emobolization of liver cancer via arterial access from the radial artery versus conventional transfemoral arterial access. The procedures that will be followed utilizing arterial access include transarterial chemoembolization (TACE), specifically performed for hepatocellular carcinoma, and transarterial embolization (TAE) which is performed for types of liver tumors such as carcinoid tumors or liver metastases.

Conditions

Hepatic Carcinoma; Chemoembolizaton; Transarterial Embolization

Outcome Measures

Primary Outcomes (1)

• To assess potential patient preference for the performance of hepatic embolization procedures via transradial versus transfemoral approach.

  Record of patient response via administered questionnaire as well as stated patient choice in the selection of approach for the third planned procedure of a series. These findings will be correlated with additional objective data regarding complication rates.

  December, 2015 through August, 2016

Secondary Outcomes (3)

• To evaluate complication rates and severity from different modes of access.

  December, 2015 through August, 2016

• To assess ancillary procedural and patient satisfaction quality metrics between the two groups.

  December, 2015 through August, 2016

• To identify potential risk factors for complications in transradial approach.

  December, 2015 through August, 2016

Interventions

Transarterial embolization PROCEDURE

Transarterial hepatic embolization of liver cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be patients referred to Division of Vascular Interventional Radiology (VIR) at MUSC found suitable for TACE per the Barcelona Clinic Liver Cancer Staging System with stage B disease (Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and Child-Pugh A-B liver disease with or without portal vein thrombus). Our current institutional protocol to treat unresectable Hepatocellular Carcinoma(HCC) and hepatic metastatic includes three separate TACE/TAE procedures in average in order to obtain local tumor control.

You may qualify if:

• Age \> 18 years
• Selected for TACE treatment of Barcelona Clinic Liver Cancer Staging System stage B disease per current standard of care or TAE for the treatment of hepatic carcinoma
• Radial diameter of ≥2.0mm as determined by clinical and ultrasound evaluation
• Patient undergoes at least two of three courses of planned treatment with TACE/TAE per institutional protocol

You may not qualify if:

• Need for additional procedures requiring transfemoral or transradial access approach during the same hospitalization
• Patient is unable to give informed consent in accordance with guidelines established the Institutional Review Board.
• Unsuitable for radial access due lack of dual arterial supply to the hand as determined by modified Allen test.
• Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Vascular and Interventional Radiology

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: December 1, 2015
• Primary Completion: April 20, 2016
• Study Completion: August 18, 2016
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

US (1)