Hepatic CarcinomaACCESSNCT03163186
Transradial Versus Transfemoral Arterial Access in Liver Cancer Embolization: Randomized Trial to Assess Patient Outcomes and Satisfaction (BEST ACCESS Trial).
An observational study of Hepatic Carcinoma and Chemoembolizaton, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Carcinoma, Chemoembolizaton, Transarterial Embolization
- What is being tested?
- Transarterial embolization
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 18 Aug 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Transradial Versus Transfemoral Arterial Access for Transarterial Embolization Therapy of Hepatic Carcinoma: A Patient Outcomes, Satisfaction, and Cost Analysis
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.
Read the detailed description
The use of transradial (TR) access for the purpose of diagnosis and intervention in the arterial system is a well-established concept, particularly in coronary angiography, with many distinct advantages over conventional transfemoral (TF) access. The first series of 100 coronary angiographic procedures performed via TR access, published by Campeau in 19891, demonstrated 88% technical success rate and a 6% asymptomatic radial artery occlusion rate. Further experience and data accumulated with the first TR angioplasty procedure in 1992 and the first TR coronary stent placement in 1993. TR access for coronary artery interventions in the United States has grown exponentially over the past few years with the proportion of transradial percutaneous coronary interventions (PCI) procedures increasing from 1.2% in the first quarter of 2007 to 16.1% in the third quarter of 20122. And yet, its usage is largely absent in the interventional radiology and vascular surgery communities.
Reasons for this include a lack of appropriate training and equipment, but the potential advantages of TR over TF access are abundant in both coronary and non-coronary applications. Firstly, the radial artery is more superficial than the femoral artery without surrounding neurovascular structures susceptible to injury. In addition, any sustained arterial damage is significantly less detrimental because of the hand's dual arterial vascular supply. In addition, the radial artery is readily compressible regardless of the patient's body habitus. This compressibility has been shown to decrease the incidence of post-procedural bleeding complications as well as cardiac mortality during PCI3,4,5. In addition to patient safety, there are numerous benefits to overall patient comfort and convenience. For one, after TR access, patients may sit up in bed and ambulate immediately with faster discharge to home. In one randomized trial, Cooper et al demonstrated a strong patient preference, improved quality-of-life metrics, and decreased hospital costs for TR over TF access during cardiac catherization6. These benefits have yet to be empirically demonstrated for non-coronary applications like transarterial hepatic embolization. Even so, these potential benefits are of even greater importance in the patient population undergoing chemoembolization/bland embolization given the chemo/bland embolization's association with nausea and emesis post intervention.
Ultimately, complications with TR approach have proven rare in both coronary and noncoronary applications. Most commonly, a local small hematoma may develop with mild pain, usually treated with NSAIDS if necessary. Despite meticulous hemostatic technique, radial artery thrombosis may occur. Nevertheless, this thrombosis almost always remains asymptomatic7, at least partially because a modified Allen's test is performed before all procedures using TR access. The Allen's test is a clincal examination technique that determines the presence of dual arterial supply to the hand and palmar arch patency in the event of radial artery occlusion. Additional possible complications of TR access include radial artery pseudoaneurysm, spasm, dissection, digit ischemia, as well as cerebral infarction, but all of the following have proven to be extremely low incidence particularly with the usage of intraprocedural heparinization and vasodilators, which are included in our procedure protocol.
Finally and increasing more importantly in the modern era of health care reform, TR access offers many benefits to hospital costs and patient satisfaction. Many studies have demonstrated decreased costs associated with TR versus traditional TF access5,8,9, primarily due to the nonutilization of arterial closure devices and decreased readmission for bleeding complications. International studies have long promoted TR access as a feasible, safe, and well tolerated method for performing hepatic transarterial chemoembolization10,11. In a recent series performed in the United States, technical success was obtained in all procedures. Furthermore, 100% of patients who underwent both TF and TR access preferred TR over TF access12. Our study seeks to further establish TR arterial access as a viable and typically preferable method for performing hepatic transarterial embolization as well as refine patient suitability criteria for TR access.
- Being tested
- Transarterial embolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial embolizationProcedure or surgery
Transarterial hepatic embolization of liver cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December, 2015 through August, 2016
Secondary outcomes (3)
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.
Measured: December, 2015 through August, 2016
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.
Measured: December, 2015 through August, 2016
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.
Measured: December, 2015 through August, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Dec 2015
- Primary completion20 Apr 2016
- Study completion18 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CarcinomaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Yamada, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163186
- Sponsor's protocol ID
- PRO33987
- Acronym
- ACCESS
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transradial Versus Transfemoral Arterial Access for Transarterial Embolization Therapy of Hepatic Carcinoma: A Patient Outcomes, Satisfaction, and Cost Analysis
- ClinicalTrials.gov ID
- NCT03163186
- Acronym / sponsor ID
- ACCESS / PRO33987
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 20 Apr 2016 (actual)
- Study completion
- 18 Aug 2016 (actual)
- First posted
- 22 May 2017 (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.
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.
Detailed description
The use of transradial (TR) access for the purpose of diagnosis and intervention in the arterial system is a well-established concept, particularly in coronary angiography, with many distinct advantages over conventional transfemoral (TF) access. The first series of 100 coronary angiographic procedures performed via TR access, published by Campeau in 19891, demonstrated 88% technical success rate and a 6% asymptomatic radial artery occlusion rate. Further experience and data accumulated with the first TR angioplasty procedure in 1992 and the first TR coronary stent placement in 1993. TR access for coronary artery interventions in the United States has grown exponentially over the past few years with the proportion of transradial percutaneous coronary interventions (PCI) procedures increasing from 1.2% in the first quarter of 2007 to 16.1% in the third quarter of 20122. And yet, its usage is largely absent in the interventional radiology and vascular surgery communities.
Reasons for this include a lack of appropriate training and equipment, but the potential advantages of TR over TF access are abundant in both coronary and non-coronary applications. Firstly, the radial artery is more superficial than the femoral artery without surrounding neurovascular structures susceptible to injury. In addition, any sustained arterial damage is significantly less detrimental because of the hand's dual arterial vascular supply. In addition, the radial artery is readily compressible regardless of the patient's body habitus. This compressibility has been shown to decrease the incidence of post-procedural bleeding complications as well as cardiac mortality during PCI3,4,5. In addition to patient safety, there are numerous benefits to overall patient comfort and convenience. For one, after TR access, patients may sit up in bed and ambulate immediately with faster discharge to home. In one randomized trial, Cooper et al demonstrated a strong patient preference, improved quality-of-life metrics, and decreased hospital costs for TR over TF access during cardiac catherization6. These benefits have yet to be empirically demonstrated for non-coronary applications like transarterial hepatic embolization. Even so, these potential benefits are of even greater importance in the patient population undergoing chemoembolization/bland embolization given the chemo/bland embolization's association with nausea and emesis post intervention.
Ultimately, complications with TR approach have proven rare in both coronary and noncoronary applications. Most commonly, a local small hematoma may develop with mild pain, usually treated with NSAIDS if necessary. Despite meticulous hemostatic technique, radial artery thrombosis may occur. Nevertheless, this thrombosis almost always remains asymptomatic7, at least partially because a modified Allen's test is performed before all procedures using TR access. The Allen's test is a clincal examination technique that determines the presence of dual arterial supply to the hand and palmar arch patency in the event of radial artery occlusion. Additional possible complications of TR access include radial artery pseudoaneurysm, spasm, dissection, digit ischemia, as well as cerebral infarction, but all of the following have proven to be extremely low incidence particularly with the usage of intraprocedural heparinization and vasodilators, which are included in our procedure protocol.
Finally and increasing more importantly in the modern era of health care reform, TR access offers many benefits to hospital costs and patient satisfaction. Many studies have demonstrated decreased costs associated with TR versus traditional TF access5,8,9, primarily due to the nonutilization of arterial closure devices and decreased readmission for bleeding complications. International studies have long promoted TR access as a feasible, safe, and well tolerated method for performing hepatic transarterial chemoembolization10,11. In a recent series performed in the United States, technical success was obtained in all procedures. Furthermore, 100% of patients who underwent both TF and TR access preferred TR over TF access12. Our study seeks to further establish TR arterial access as a viable and typically preferable method for performing hepatic transarterial embolization as well as refine patient suitability criteria for TR access.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Transarterial embolizationTransarterial hepatic embolization of liver cancer | Procedure or surgery | – |
Primary outcome
To assess potential patient preference for the performance of hepatic embolization procedures via transradial versus transfemoral approach.
Time frame: December, 2015 through August, 2016
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.
3 secondary outcomes
To evaluate complication rates and severity from different modes of access.
Time frame: December, 2015 through August, 2016
To assess ancillary procedural and patient satisfaction quality metrics between the two groups.
Time frame: December, 2015 through August, 2016
To identify potential risk factors for complications in transradial approach.
Time frame: December, 2015 through August, 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Carcinoma and Chemoembolizaton, run by Medical University of South Carolina at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 May 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess potential patient preference for the performance of hepatic embolization procedures via transradial versus transfemoral approach. (time frame: December, 2015 through August, 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2017.