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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03163186
Other study ID # PRO33987
Secondary ID
Status Completed
Phase N/A
First received May 19, 2017
Last updated May 19, 2017
Start date December 1, 2015
Est. completion date August 18, 2016

Study information

Verified date May 2017
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Intervention

Procedure:
Transarterial embolization
Transarterial hepatic embolization of liver cancer

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To evaluate complication rates and severity from different modes of access. This data will be collected from imaging, clinical, and laboratory measures of complications collected at both the one day and follow-up clinic visits. December, 2015 through August, 2016
Secondary To assess ancillary procedural and patient satisfaction quality metrics between the two groups. Procedural details include contrast amount, fluoroscopy time, operator exposure, and cost will also be collected and compared between the two treatment groups. Additional patient quality of life endpoints will be also be compared based on the results of items 1 through 7 on the post-procedure questionnaire. December, 2015 through August, 2016
Secondary To identify potential risk factors for complications in transradial approach. This will be determined by evaluating association of complication data with pre-procedural laboratory and imaging evaluation. December, 2015 through August, 2016
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