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Endoscopic ultrasound-guided biliary drainage using a newly designed metal stent with a thin delivery system: a preclinical study in phantom and porcine models

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Abstract

Purpose

This study was designed to evaluate the feasibility and safety of a newly designed self-expandable metal stent for endoscopic ultrasound-guided biliary drainage (EUS-BD) when it was delivered via three different stent delivery systems: a 7.5Fr delivery catheter with a bullet-shaped tip (7.5Fr-bullet), a 7Fr catheter with a bullet-shaped tip (7Fr-bullet), or a 7Fr catheter with a tee-shaped tip (7Fr-tee).

Methods

This experimental study utilized a porcine model of biliary dilatation involving ten pigs. In the animal study, technical feasibility and clinical outcomes of the stent when placed with each of the delivery systems were examined. In addition, a phantom model was used to measure the resistance of these delivery systems to advancement.

Results

Phantom experiments showed that, compared with 7Fr-bullet, 7Fr-tee had less resistance force to the advancement of the stent delivery system. EUS-BD was technically successful in all ten pigs. Fistulous tract dilation was necessary in 100% (2/2), 75% (3/4), and 0% (0/4) of the pigs that underwent EUS-BD using 7.5Fr-bullet, 7Fr-bullet, and 7Fr-tee, respectively. There were no procedure-related complications.

Conclusion

Our newly designed metal stent may be feasible and safe for EUS-BD, particularly when delivered by 7Fr-tee, because it eliminates the need for fistulous tract dilation.

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Acknowledgements

The present study was supported by grants from the Research and Development Committee Program of The Japan Society of Ultrasonics in Medicine, and the Japan Society for the Promotion of Science (Grant No. 16K09410). Piolax Medical Devices, Inc. provided stent samples. The funders did not participate in the study design; the collection, analysis, and interpretation of the data; the writing of the report; or the decision to submit the article for publication. We would also like to thank Jun Sumiya and Kyosuke Shirakawa of Piolax Medical Devices, Inc. (Yokohama, Japan) for their efforts in developing the newly designed metal stent.

Author information

Authors and Affiliations

  1. Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan

    Kosuke Minaga, Hajime Imai, Takeshi Miyata, Kentaro Yamao & Masatoshi Kudo

  2. Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan

    Masayuki Kitano, Masahiro Itonaga, Takashi Tamura & Junya Nuta

  3. Department of Human Pathology, Wakayama Medical University, Wakayama, Japan

    Kenji Warigaya

Authors
  1. Kosuke Minaga
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  2. Masayuki Kitano
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  3. Masahiro Itonaga
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  4. Hajime Imai
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  5. Takeshi Miyata
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  6. Kentaro Yamao
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  7. Takashi Tamura
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  8. Junya Nuta
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  9. Kenji Warigaya
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  10. Masatoshi Kudo
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Contributions

All authors helped to perform the research; Kosuke Minaga: manuscript writing and performing experiments; Masayuki Kitano: conception and design of the study, performing endoscopic procedures, and data analysis; Masahiro Itonaga, Hajime Imai, Takeshi Miyata, Kentaro Yamao, Takashi Tamura, and Junya Nuta: performing experiments and data analysis; Kenji Warigaya: pathological assessment; Masatoshi Kudo: conception and design of the study, assistance in writing the manuscript.

Corresponding author

Correspondence to Masayuki Kitano.

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Conflict of interest

The following authors declare no conflicts of interest: K. Minaga, M. Kitano, M. Itonaga, H. Imai, T. Miyata, K. Yamao, T. Tamura, J. Nuta, K. Warigaya, and M. Kudo.

Ethical statements

All institutional and national guidelines for the care and use of laboratory animals were followed.

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Minaga, K., Kitano, M., Itonaga, M. et al. Endoscopic ultrasound-guided biliary drainage using a newly designed metal stent with a thin delivery system: a preclinical study in phantom and porcine models. J Med Ultrasonics 45, 391–397 (2018). https://doi.org/10.1007/s10396-017-0850-1

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  • DOI: https://doi.org/10.1007/s10396-017-0850-1

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