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Phase II Trial of Transarterial Embolization Using an n-Butyl-2-Cyanoacrylate/Lipiodol Mixture (JIVROSG-0802)

  • Shunsuke Sugawara
  • Yasuaki Arai
  • Miyuki Sone
  • Tsuneo Ishiguchi
  • Akira Kitagawa
  • Takeshi Aramaki
  • Rui Sato
  • Hiroyuki Morishita
  • Yoshito Takeuchi
  • Yoshitaka Inaba
Clinical Investigation Arterial Interventions
  • 11 Downloads
Part of the following topical collections:
  1. Arterial Interventions

Abstract

Purpose

To evaluate the embolic effect and the safety of transarterial embolization (TAE) using n-butyl-2-cyanoacrylate (NBCA) in a prospective multicenter trial.

Materials and Methods

This study was an open-label, multicenter, phase II trial. The inclusion criteria were (1) active bleeding or pseudoaneurysm, (2) true aneurysm, (3) arteriovenous malformation (except cerebral lesion), (4) arteriovenous fistula, or (5) need for arterial distribution before transarterial treatment. Selective TAE with NBCA diluted 2–10 times was performed. The primary endpoint was the success rate of embolization with a per-patient analysis based on the angiographic findings. Secondary endpoints were safety, evaluated based on Common Terminology Criteria for Adverse Events (CTCAE) version 4, and the success rate of embolization with a per-vessel calculation.

Results

Sixty-five patients were initially enrolled, but due to protocol violation in two patients, efficacy was ultimately analyzed in 63 patients (103 vessels) and safety was analyzed in 64 patients. The success rate per patient was 98.4% (62/63; 95% confidence interval (CI), 91.5–100.00), and the success rate per vessel was 99.0% (102/103; 95% CI, 94.7–100.0). Adverse events of grade 3 or above based on CTCAE version 4 occurred in 22/64 patients (34.4%). Twelve intraoperative or postoperative adverse events grade 3 or above, which may have been related to embolization using NBCA, occurred in 11/64 patients (17.2%). Three patients died after embolization using NBCA, but their deaths were unrelated to TAE.

Conclusion

In this prospective multicenter clinical trial, the efficacy of TAE using NBCA was 98.4% and adverse events were clinically acceptable.

Level of Evidence

Level 3b.

Keywords

Transarterial embolization NBCA Phase II study 

Notes

Funding

This research was supported by the Practical Research for Innovative Cancer Control (16ck0106058h0003) from the Japan Agency for Medical Research and Development (AMED), Health and Labor Sciences Research Grant (H26-055) from the Ministry of Health, Labour and Welfare of Japan, and the National Cancer Center Research and Development Fund (26-A-27).

Compliance with Ethical Standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Consent for Publication

Consent for publication was obtained for every individual person’s data included in the study.

Supplementary material

270_2018_2141_MOESM1_ESM.docx (13 kb)
Supplementary material 1 (DOCX 14 kb)

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2018

Authors and Affiliations

  • Shunsuke Sugawara
    • 1
  • Yasuaki Arai
    • 1
  • Miyuki Sone
    • 1
  • Tsuneo Ishiguchi
    • 2
  • Akira Kitagawa
    • 2
  • Takeshi Aramaki
    • 3
  • Rui Sato
    • 3
  • Hiroyuki Morishita
    • 4
  • Yoshito Takeuchi
    • 5
    • 7
  • Yoshitaka Inaba
    • 6
  1. 1.Department of Diagnostic RadiologyNational Cancer Center HospitalTokyoJapan
  2. 2.Department of RadiologyAichi Medical UniversityNagakuteJapan
  3. 3.Division of Interventional RadiologyShizuoka Cancer CenterNagaizumi-choJapan
  4. 4.Department of Diagnostic RadiologyJapan Red Cross Kyoto Daiichi HospitalKyotoJapan
  5. 5.Department of RadiologyKyoto Prefectural University of Medicine, North Medical CenterYosagunJapan
  6. 6.Department of Diagnostic and Interventional RadiologyAichi Cancer Center HospitalNagoyaJapan
  7. 7.Department of RadiologyFukuchiyama City HospitalFukuchiyamaJapan

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