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Efficacy and Safety of Drug Eluting Beads TACE in Treatment of HCC in Egyptian Patients

NCT03007225 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-10-22

Study results available
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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

Conditions

Interventions

DRUG

Trans-arterial chemoembolization (TACE)

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.

DRUG

TACE with Drug Eluting Beads procedure

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).

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-08-31
Completion
2016-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03007225 on ClinicalTrials.gov