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

  • Clinical Investigation
  • Arterial Interventions
  • Published:
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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.

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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).

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Authors and Affiliations

  1. Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Shunsuke Sugawara, Yasuaki Arai & Miyuki Sone

  2. Department of Radiology, Aichi Medical University, 1-1 Yazako Karimata, Nagakute, Aichi, 480-1195, Japan

    Tsuneo Ishiguchi & Akira Kitagawa

  3. Division of Interventional Radiology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Shizuoka, 411-8777, Japan

    Takeshi Aramaki & Rui Sato

  4. Department of Diagnostic Radiology, Japan Red Cross Kyoto Daiichi Hospital, 15-749 Honmachi, Higashiyama, Kyoto, 605-0981, Japan

    Hiroyuki Morishita

  5. Department of Radiology, Kyoto Prefectural University of Medicine, North Medical Center, 481, Otokoyama, Yosanocho, Yosagun, Kyoto, 629-2261, Japan

    Yoshito Takeuchi

  6. Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan

    Yoshitaka Inaba

  7. Department of Radiology, Fukuchiyama City Hospital, 231 Atsunakacho, Fukuchiyama, Kyoto, 620-8505, Japan

    Yoshito Takeuchi

Authors
  1. Shunsuke Sugawara
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  2. Yasuaki Arai
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  10. Yoshitaka Inaba
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Corresponding author

Correspondence to Shunsuke Sugawara.

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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.

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Sugawara, S., Arai, Y., Sone, M. et al. Phase II Trial of Transarterial Embolization Using an n-Butyl-2-Cyanoacrylate/Lipiodol Mixture (JIVROSG-0802). Cardiovasc Intervent Radiol 42, 534–541 (2019). https://doi.org/10.1007/s00270-018-2141-7

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  • DOI: https://doi.org/10.1007/s00270-018-2141-7

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