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Utility and Safety of a Novel Fully Covered Metal Stent in Unresectable Distal Malignant Biliary Obstruction

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Abstract

Background

Self-expandable metal stents (SEMSs) are widely used in patients with distal malignant biliary obstruction. A SEMS that can avoid occlusion as much as possible is desirable.

Aims

The aim of this multicenter single-arm prospective study was to assess the clinical effectiveness and safety of a novel fully covered braided SEMS.

Methods

We enrolled consecutive patients with distal malignant biliary obstruction between February 2016 and November 2017 at ten tertiary-care medical centers.

Results

We included 79 patients with a median age of 76 years; 47 (59.5%) patients were men. The technical and clinical success rate was 98.7% and 93.6%, respectively. Recurrent biliary obstruction occurred in 14 patients (17.9%); stent ingrowth, overgrowth, migration, and other occurred in five (6.4%), four (5.1%), four (5.1%), and one (1.3%) patients, respectively. All reinterventions in patients with recurrent biliary obstruction were successful via the transpapillary approach. Adverse events occurred in 15 patients (19.2%); cholangitis, pancreatitis, and others occurred in ten (12.8%), three (3.8%), and two (2.6%) patients, respectively. The stent patency probability at 6 months was 48.5%. Median time to stent patency was 171 days, median time to recurrent biliary obstruction was 536 days, and median survival time was 195 days.

Conclusions

We confirmed the utility and safety of a novel fully covered braided SEMS with low axial force and high radial force in patients with malignance biliary obstruction. This novel SEMS is recommended in patients with distal malignant biliary obstruction.

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Acknowledgments

We thank Jane Charbonneau, DVM, from Edanz Group (www.edanzediting.com/ac) for editing a draft of this manuscript.

Funding

None.

Author information

Authors and Affiliations

  1. Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, 589-8511, Japan

    Kentaro Yamao, Mamoru Takenaka & Masatoshi Kudo

  2. The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Osaka, 569-8686, Japan

    Takeshi Ogura

  3. Department of Gastroenterology, Bell Land General Hospital, Sakai, Osaka, 599-8247, Japan

    Hiroaki Hashimoto

  4. Department of Gastroenterology, Japanese Red Cross Wakayama Medical Center, Wakayama, 640-8558, Japan

    Hisakazu Matsumoto

  5. Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Osaka, 560-8565, Japan

    Masashi Yamamoto

  6. The Third Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, 573-1191, Japan

    Tsukasa Ikeura

  7. Digestive Disease Center, Kitano Hospital, Osaka, 530-8480, Japan

    Akira Kurita

  8. Department of Gastroenterology, Takarazuka City Hospital, Takarazuka, Osaka, 665-0827, Japan

    Zhao Liang Li

  9. Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Hyogo, 650-0017, Japan

    Hideyuki Shiomi

  10. Clinical Research Center, Kindai University Hospital, Osaka-Sayama, Osaka, 589-8511, Japan

    Yasutaka Chiba

  11. Department of Gastroenterology, Kita-Harima Medical Center, Ono, Hyogo, 675-1392, Japan

    Tsuyoshi Sanuki

Authors
  1. Kentaro Yamao
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  2. Mamoru Takenaka
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  3. Takeshi Ogura
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  6. Masashi Yamamoto
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  7. Tsukasa Ikeura
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  8. Akira Kurita
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  9. Zhao Liang Li
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  10. Hideyuki Shiomi
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  11. Yasutaka Chiba
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  12. Masatoshi Kudo
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  13. Tsuyoshi Sanuki
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Corresponding author

Correspondence to Kentaro Yamao.

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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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Yamao, K., Takenaka, M., Ogura, T. et al. Utility and Safety of a Novel Fully Covered Metal Stent in Unresectable Distal Malignant Biliary Obstruction. Dig Dis Sci 65, 3702–3709 (2020). https://doi.org/10.1007/s10620-020-06114-8

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  • DOI: https://doi.org/10.1007/s10620-020-06114-8

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