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Reinforced staplers for distal pancreatectomy

  • ORIGINAL ARTICLE
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Abstract

Purpose

The safety and efficacy of reinforced staplers during distal pancreatectomy (DP) remain controversial because of the small sample size. This multicenter single-arm prospective study aims to evaluate the safety and efficacy of reinforced staplers with bioabsorbable material during DP.

Methods

Between October 2014 and August 2015, 121 patients scheduled for DP were enrolled in this study at 11 institutions in Japan. The primary endpoint was the incidence of clinically relevant pancreatic fistula. Protocol treatment was defined as “distal pancreatectomy using reinforced staplers.”

Results

Per-protocol analysis of 105 patients was performed; 16 of the patients were excluded based on discontinuation of protocol treatment criteria. Clinically relevant pancreatic fistula occurred in 13 (12.4%) of 105 patients. The overall morbidity rate was 29.5% (31 of 105 patients) and severe complication (Clavien classification IIIa or more) was 10.5% (11/105). Mortality rate was 0%, although reoperations were performed on two patients (1.9%). Multivariate logistic regression analysis of independent risk factors for clinically relevant pancreatic fistula after DP using reinforced stapler closure was operative time more than 240 min (P = 0.047, odds ratio 5.79), registration numbers less than 10 (P = 0.046, odds ratio 13.01), and staple line hemorrhage (P = 0.003, odds ratio 16.34).

Conclusion

This study confirms the safety of reinforced staplers for pancreatic stump closure during DP. However, the efficacy of reinforced staplers for decreasing clinically relevant pancreatic fistula could not be drawn from this study.

Trial registration

This prospective study was registered with ClinicalTrials.gov (NCT02270554) and UMIN Clinical Trial Registry (UMIN000015384).

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Author information

Authors and Affiliations

  1. Second Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan

    Manabu Kawai, Seiko Hirono, Ken-ichi Okada & Hiroki Yamaue

  2. Department of Surgery, Kansai Medical University, Hirakata, Japan

    Sohei Satoi, Hiroaki Yanagimoto & Masanori Kon

  3. Department of Surgery, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan

    Yoshiaki Murakami & Naru Kondo

  4. Department of Surgery, Nara Medical University, Kashihara, Japan

    Masayuki Sho & Takahiro Akahori

  5. Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan

    Hirochika Toyama & Takumi Fukumoto

  6. Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan

    Tsutomu Fujii

  7. Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kindai University, Higashi-osaka, Japan

    Ippei Matsumoto

  8. Department of Surgery, Osaka University Graduate School of Medicine, Suita, Japan

    Hidetoshi Eguchi

  9. Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan

    Hisashi Ikoma

  10. Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan

    Yutaka Takeda

  11. Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Nishinomiya, Japan

    Jiro Fujimoto

Authors
  1. Manabu Kawai
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  2. Seiko Hirono
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  3. Ken-ichi Okada
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  4. Sohei Satoi
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  5. Hiroaki Yanagimoto
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  6. Masanori Kon
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  7. Yoshiaki Murakami
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  8. Naru Kondo
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  9. Masayuki Sho
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  10. Takahiro Akahori
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  11. Hirochika Toyama
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  12. Takumi Fukumoto
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  13. Tsutomu Fujii
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  14. Ippei Matsumoto
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  15. Hidetoshi Eguchi
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  16. Hisashi Ikoma
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  17. Yutaka Takeda
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  18. Jiro Fujimoto
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  19. Hiroki Yamaue
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Corresponding author

Correspondence to Hiroki Yamaue.

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The authors declare that they have no conflict of interest.

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Kawai, M., Hirono, S., Okada, Ki. et al. Reinforced staplers for distal pancreatectomy. Langenbecks Arch Surg 402, 1197–1204 (2017). https://doi.org/10.1007/s00423-017-1634-1

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  • DOI: https://doi.org/10.1007/s00423-017-1634-1

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