Hepatic Carcinoma Clinical Trial
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.
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.
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