Safety and Efficacy of DEB-TACE Performed With a Novel Reflux-control Microcatheter in Patients With HCC

Summary

Participation Requirements

Description

Microcatheters are commonly used during most arterial embolization procedures. SEQURE® (Guerbet, France) is an innovative reflux-control microcatheter for peripheral embolization procedures which relies on flow dynamics as the foundation of its' mechanism of action. It can optimize the delivery of c...

Microcatheters are commonly used during most arterial embolization procedures. SEQURE® (Guerbet, France) is an innovative reflux-control microcatheter for peripheral embolization procedures which relies on flow dynamics as the foundation of its' mechanism of action. It can optimize the delivery of calibrated microspheres of specific sizes. The device presents as a regular microcatheter with a non-tapered internal lumen for delivery of embolics (typically in suspension with contrast media), and 2 radiopaque markers (placed at a distance of 11 mm) at the tip (distal marker being at 0.5-1 mm from the point of exit). Near the distal atraumatic tip, between the two markers, it has side slits (approximately 50 µm in width) which allow contrast media to exit radially in addition to the standard fluid flow through the distal tip of the catheter. The contrast media that comes out of the side-holes creates a turbulence in the space surrounding the slits, between microcatheter and vessel, which acts as a fluid barrier in that given portion. This fluid-dynamic barrier redirects the beads that tend to upstream reflux back to their flow-directed trajectory, preventing the beads from migrating in non-target areas, and thus eliminating, or strongly reducing, undesired non-target embolization (NTE). Moreover, SEQURE® allows for haemodynamic arrangement to be preserved, by favoring and maintaining unaltered the natural blood flow. Under fluoroscopy, the radial flow of contrast media exiting through the side holes in the SEQURE® microcatheter can be seen, giving the physician indication of the vessel flow dynamics. Lesions were identified and then treated supra-selectively with the microcatheter, with the embolic materials infused in a slow and controlled manner, in order to reduce reflux into non-target branches HYPOTHESIS: The use of 100 micron-TANDEM ® spheres will be studied with the synergistic effect of being administered through SEQURE® microcatheter anti-reflux protection system, which may allow the administration of the maximum doses of doxorubicin, avoiding the undesired oclussion of collateral arterial segments (SYNERGIC EFFECT) in a prospective study in patients with hepatocellular carcinoma early-intermediate stage. PATIENT SELECTION: Between October 2020 and December 2021, and expected number of 30 patients will be treated. The diagnosis of Hepatocellular carcinoma (HCC) will confirm in accordance with the American Association for the Study of Liver Diseases guidelines and HCC staged according to Barcelona Clinic Liver Cancer (BCLC) system. DEB-TACE is indicated according to clinical practice guidelines referred above. TECHNICAL PROCEDURE: The embolization will be performed using TANDEM ® spheres (each cc of spheres can be loaded with up to 50 mg of doxorubicin. The maximum dose of doxorubicin used per procedure was 150 mg, corresponding to 3 cc of spheres) and SEQURE ® microcatheter in a super-selective tumour´s arterial position avoiding undesired arterial branches. The procedure will consider super-selective when the micro-catheter tip reached the tumour feeding artery. Each cc of microspheres will mix with 7-10 cc of non-ionic contrast medium. Embolization endpoint is considered vascular stasis or 150 mg of Doxorubin administered. OBJECTIVES AND END-POINTS: Efficacy: Technical success will be defined as a composite outcome measurement: ability to place the microcatheter inside the required vascular segment and qualitative assessment of microspheres deposition in the target tumour. Time to Progression (TTP) [Time Frame: 6 months]. Time at which progression is first observed in a tumor assessment according to mRECIST as assessed by CT or MRI. Objective Response Rate (ORR) and Disease Control Rate (DCR) [Time Frame: Assessed at 1, 3, and 6 months after first treatment]. ORR is defined as a complete or partial response among the total number of cases and DCR is defined as a complete, partial response or stable disease among the total number of cases , according to mRECIST evaluated by CT or MRI. Time to retreatment included as consequential secondary objective. Safety: Adverse Events (AEs) and Serious Adverse Events (SAE) [Time Frame: Assessed at 1, 3, and 6 months after first treatment. The incidence of emerging AE and SAE will be summarized according to standardized qualification criteria [Journal of Vascular Interventional Radiology (JVIR) SAE], including pancreatitis, cholecystitis, clinical presentations, postembolization syndrome (PES), etc. Non Target embolization (NTE) by thorough angiographic assessment of the whole liver vasculature after TACE, as well as Cone Beam Computed Tomography (CBCT) performed immediately following embolization (within 30 minutes from the end of procedure) to evaluate off-target distribution. Health-Related Quality of Life questionary (HRQOL): pre-treatment and post-treatment quality of life assessment using the specific questionnaire for functional assessment for cancer treatment (FACT-G). DATA COLLECTION AND FOLLOW-UP: The information will be collected through the electronic database of the patient (includes laboratory data). Patients will be evaluated starting from the date of inclusion as candidates for TACE treatment, and followed up for 6 months (unless patients are lost to clinical follow-up or death occurs). Mortality data are obtainable by searching the electronic history of the patient. Changes in the serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase (ALP), bilirubin, albumin and patients' complete hematological profile, as well as serum lipase and amylase levels within the 1st week post-TACE to detect pancreatitis, will be evaluated at the following time-points: pre-embolization, at one month, three months, and six months. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) with contrast will be performed at the same time-points as just indicated; modified Response Evaluation Criteria in Solid Tumors ( m-RECIST) will be used, and images will be assessed by two experienced radiologists (any discordant interpretation will be solved through team consensus). All serologic toxicities would be classified according to common terminology criteria for adverse effects. On this scale, severe hepato-toxicity (grade 3) is classified as the increase of up to 5 times the normal limit of AST, ALT, FA or the increase of bilirubin level to over 3 g/dl.

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