Efficacy and Safety of Drug Eluting Beads TACE in Treatment of HCC in Egyptian Patients
Condition: HepatoCellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Intervention: Trans-arterial chemoembolization (TACE); TACE with Drug Eluting Beads procedure
Intervention description: TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography of the Coeliac and Hepatic arteries to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.
Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed by cutting gel foam sheets into small pledges mannully then mixed with a contrast material and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved.; The same was done as cTACE till the super selective catheterization of the feeding artery.
Loading of the beads with Doxorubicin hydrochloride (100-150 mg) was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter (Cobra head catheter; Cordis, USA) or 2.7F microcatheter (Progreat; Terumo, Japan).
Intervention MeSH terms: Chlorotrianisene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study aimed to to compare the conventional transarterial chemoembolization (cTACE) with
      chemoembolization using doxorubicin drug eluting beads (DEB-TACE) for the treatment of
      hepatocellular carcinoma regarding short term efficacy and safety in first 3 months after
      embolization
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of HCC according to the European association of study of liver
             diseases

          -  Early stage HCC (Stage A), using the Barcelona Clinic Liver Cancer (BCLC) staging
             system, (single or 3 nodules < 3cm PS 0) whenever curative measures were
             contraindicated and BCLC stage B (intermediate HCC).

          -  Patent portal vein and its main branches

          -  Informed consent from all participants before enrollment in the study.

        Exclusion Criteria:

          -  Patients with Child class C according to Child classification (BCLC D).

          -  Patients with diffuse HCC (non-measurable lesion).

          -  Patients with thrombosis of main portal vein or one of its main branches (BCLC C).

          -  Patients with extra hepatic invasion.

          -  patients refused to participate in the study