Efficacy and Safety of Drug Eluting Beads TACE in Treatment of HCC in Egyptian Patients
Condition: HepatoCellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      This prospective case control was conducted at the Department of Tropical Medicine and HCC
      Clinic, Ain Shams University Hospitals (Cairo, Egypt), The patients were divided according to
      the line of treatment into 2 groups:

        1. Group (I): Twenty-five patients underwent Chemoembolization with Drug eluting beads.

        2. Group (II): Twenty-five patients underwent conventional Chemoembolization (cTACE)

      The total number of procedures was 77 sessions (37 sessions of TACE with beads and 40
      sessions of conventional TACE).Post-procedure follow up:

      Schedule of follow up:

      All included patients were checked at:

        1. One week after the procedure to detect early post chemoembolization complications and
           Patients were subjected to Liver function tests, Kidney function tests, complete blood
           count and Abdominal Ultrasound.

        2. One and four months after the maneuver.

      Patients were subjected to the following in each visit:

        1. Complete History taking

        2. Thorough clinical examination

        3. Laboratory Investigations including:

             1. Liver function tests

             2. Kidney function tests

             3. CBC

             4. Serum alpha-fetoprotein.

        4. Triphasic pelvi-abdominal CT Follow up imaging was performed at the first and fourth
           months after embolization and every 3 months thereafter. Repeated embolization was
           scheduled "on demand" basis, if there was residual viable tumor deemed unsuitable for
           radiofrequency ablation or surgery.
    

Intervention name(s): Trans-arterial chemoembolization (TACE); TACE with Drug Eluting Beads procedure
Intervention type(s): Drug; Drug
Intervention description(s): 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).
Other intervention name(s): TACE; DEB-TACE
Intervention MeSH terms: Chlorotrianisene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment