Hepatic Arterial Embolization of Hepatocellular Carcinoma With a Doxorubicin Eluting Bead
Patients will be given IV fluids and premedication with 500 mg metronidazole, 10 mg
dexamethasone, and 8 mg ondansetron to prevent infection, limit pain and nausea. The femoral
artery will be accessed and a catheter advanced into the superior mesenteric artery.
Positioning of all catheters will be confirmed by injection of radiographic contrast
material. Superior mesenteric angiography will be performed with images obtained through the
portal venous phase to confirm patency and flow direction of the portal vein and determine
the presence of aberrant supply to the right lobe of the liver by the superior mesenteric
artery. The catheter will then be advanced into the celiac artery. Celiac angiography will
be performed to determine remainder of the hepatic arterial anatomy. Selection of the tumor
bearing artery will then be performed with a microcatheter which is advanced through the
catheter in the celiac artery origin. Selection will be guided by fluoroscopy and will be at
the lobar level or peripherally in all cases. Once the feeding vessel has been selected and
confirmed by contrast injection, the physician will initiate embolization with LC Beads. Up
to two vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um
LC Beads with 37.5 mg/mL doxorubicin will be prepared. The LC Beads will be mixed with
radiographic contrast to ensure fluoroscopic visibility during injection. Under careful
fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of
500-700 um LC Beads. If the artery reaches stasis prior to administration of both vials, the
residual volume of LC Beads will be noted on the surgical report form. If after
administration of the DEB, there is residual antegrade flow in the feeding artery, it will
be treated with bland embolization similar to chemoembolization. After confirming that the
artery is appropriately treated, all catheters and guidewires will be removed from the
femoral artery and hemostasis obtained.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To collect data on patients with hepatocellular carcinoma (HCC) being treated with chemoembolization with doxorubicin eluting beads (DEB).
4-6 weeks after initial treament, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
Nael E. Saad, M.D.
Mallinckrodt Institute of Radiology/Washington University School of Medicine
United States: Food and Drug Administration
|Barnes-Jewish Hospital/Washington Univesity School of Medicine||St. Louis, Missouri 63110|