Balloon-occluded chemoembolization for hepatocellular carcinoma: a prospective study of safety, feasibility and outcomes

Abstract

Aim: Evaluation of safety and efficacy of selective balloon-occluded transarterial chemoembolization using polyethylene glycol embolizing microspheres in patients with hepatocellular carcinoma. Materials & methods: Twenty-four consecutive patients were included in this monocentric prospective trial. Adverse events were evaluated at 24 h and 1 month. Imaging response according to modified response evaluation criteria in solid tumors was assessed at 1, 3 and 6 months. Results: The median time of follow-up was of 22.8 months (interquartile range (IQR) 17.38–26.22). Clinical grade 1/2 toxicities (0% >grade 2) were reported in 25.7% of patients, with abdominal pain being the most frequent complication (17.1%). No 30-days mortalities or liver decompensation were observed. The 1-month follow-up MRI showed an overall response rate of 74.3% Conclusion: Balloon-occluded transarterial chemoembolization was shown to be safe and effective.

Tweetable abstract

We report a new technique of chemoembolization for liver cancer that allows to selectively treat tumor nodules with fewer side effects and better tolerance. #chemoembolizationforHCC #improvinglocoregionaltreatmentinHCC #balloonmicrocatheterforTACE

Keywords::

• balloon-occluded transarterial chemoembolization using drug-eluting microspheres
• hepatocellular carcinoma
• polyethylene glycol embolizing microspheres
• transcatheter arterial chemoembolization

Author contributions

A-M Bucalau contributed in the investigation and writing of original draft. I Tancredi and R Leveque performed the B-DEM-TACE procedures. M Pezzullo and S Picchia contributed in the imaging validation. J-L Van Laethem contributed in drafting methodology. G Verset, I Tacredi and R Leveque contributed in conceptualization and supervision of the study and manuscript.

Financial & competing interests disclosure

A-M Bucalau, M Pezzullo, S Picchia and J-L Van Laethem have no conflicts to declare. I Tancredi is a consultant for Terumo Europe NV and BTG International. R Leveque is a consultant for BTG International. G Verset is a consultant for Terumo Europe NV and BTG International. This is an investigator-initiated study supported by a grant from Terumo Europe NV. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

Approval was obtained from Erasmus Hospital Ethics Committee P2017/193.

Permission to reproduce material

Occlusafe® device figures reproduced with the approval from Terumo Europe NV.

Additional information

Funding

A-M Bucalau, M Pezzullo, S Picchia and J-L Van Laethem have no conflicts to declare. I Tancredi is a consultant for Terumo Europe NV and BTG International. R Leveque is a consultant for BTG International. G Verset is a consultant for Terumo Europe NV and BTG International. This is an investigator-initiated study supported by a grant from Terumo Europe NV. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.