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Annals of Surgical Oncology

, Volume 26, Issue 5, pp 1519–1527 | Cite as

A Multicenter, Randomized, Controlled Trial Comparing Reinforced Staplers with Bare Staplers During Distal Pancreatectomy (HiSCO-07 Trial)

  • Naru Kondo
  • Kenichiro Uemura
  • Naoya Nakagawa
  • Kenjiro Okada
  • Shintaro Kuroda
  • Takeshi Sudo
  • Naoto Hadano
  • Hiroyoshi Matstukawa
  • Daisuke Satoh
  • Masaru Sasaki
  • Tomoyuki Abe
  • Saburo Fukuda
  • Akihiko Oshita
  • Akira Nakashima
  • Yasushi Hashimoto
  • Hideki Ohdan
  • Yoshiaki MurakamiEmail author
  • the Hiroshima Surgical Study Group of Clinical Oncology
Pancreatic Tumors
  • 129 Downloads

Abstract

Background

Although distal pancreatectomy (DP) using a reinforced stapler is expected to reduce PF, no multicenter RCT has been performed. To investigate whether reinforced staplers reduce the incidence of clinically relevant pancreatic fistula (PF) after DP compared with staplers without reinforcement.

Methods

Between July 2016 and December 2017, patients scheduled for DP were enrolled in a multicenter, randomized, controlled trial (RCT) at nine hospitals in Hiroshima Japan. Patients were randomized either to reinforced stapler or bare stapler. The primary endpoint was incidence of clinically relevant PF. This RCT was registered with UMIN Clinical Trial Registry (UMIN000022341).

Results

A total of 122 patients were assigned to reinforced stapler (n = 61) or bare stapler (n = 61), and 119 patients (61 reinforced stapler and 59 bare stapler) were analyzed. There was no significant difference in the incidence of clinically relevant PF between the reinforced stapler and bare stapler groups (16.3% vs. 27.1%, p = 0.15). Furthermore, the rates of major complication (16.3% vs. 18.6%, p = 0.74), postpancreatectomy hemorrhage (0% vs. 3.4%, p = 0.08), and median postoperative in-hospital days (19 days vs. 20 days, p = 0.78) did not differ between the two groups. Within a subset of 82 patients in whom the thickness of pancreatic transection line was less than 14 mm, a significant difference was found in the incidence of clinically relevant PF (4.5% vs. 21.0% in the reinforced stapler vs. bare stapler groups, respectively, p = 0.01).

Conclusions

Reinforced stapler for pancreatic transection during DP does not reduce the incidence of clinically relevant PF compared to stapler without reinforcement.

Notes

Author’s Contribution

Study concepts: Naru Kondo, Kenichiro Uemura, Takeshi Sudo, Hiroyoshi Matstukawa, Shintaro Kuroda, Yoshiaki Murakami. Study design: Naru Kondo, Naoto Hadano, Daisuke Satoh, Masaru Sasaki, Tomoyuki Abe, Saburo Fukuda, Akihiko Oshita, Akira Nakashima, Yasushi Hashimoto. Data acquisition: Naru Kondo, Naoto Hadano, Naoya Nakagawa, Kenjiro Okada, Daisuke Satoh, Masaru Sasaki, Tomoyuki Abe, Saburo Fukuda, Akihiko Oshita, Akira Nakashima, Yasushi Hashimoto. Quality control of data and algorithms: Hideki Ohdan, Yoshiaki Murakami. Data analysis and interpretation: Naru Kondo, Naoya Nakagawa, Kenjiro Okada, Shintaro Kuroda. Statistical analysis: Naru Kondo, Kenichiro Uemura, Kenjiro Okada, Naoya Nakagawa. Manuscript preparation: Naru Kondo, Takeshi Sudo, Hiroyoshi Matstukawa, Masaru Sasaki, Tomoyuki Abe, Saburo Fukuda, Akihiko Oshita, Akira Nakashima,Yasushi Hashimoto. Manuscript editing: Yoshiaki Murakami, Kenichiro Uemura, Hideki Ohdan. Manuscript review: Naru Kondo, Yoshiaki Murakami.

Disclosure

None of the authors has any commercial interests associated with this study.

Ethical Approval

This study was conducted in compliance with the ethical principles of the Declaration of Helsinki and the protocol was approved by the institutional review board at each participating institution. All patients provided written informed consent before enrollment in the study.

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Copyright information

© Society of Surgical Oncology 2019

Authors and Affiliations

  • Naru Kondo
    • 1
  • Kenichiro Uemura
    • 1
  • Naoya Nakagawa
    • 1
  • Kenjiro Okada
    • 1
  • Shintaro Kuroda
    • 2
  • Takeshi Sudo
    • 3
  • Naoto Hadano
    • 3
  • Hiroyoshi Matstukawa
    • 4
  • Daisuke Satoh
    • 4
  • Masaru Sasaki
    • 5
  • Tomoyuki Abe
    • 6
  • Saburo Fukuda
    • 7
  • Akihiko Oshita
    • 8
  • Akira Nakashima
    • 9
  • Yasushi Hashimoto
    • 10
  • Hideki Ohdan
    • 2
  • Yoshiaki Murakami
    • 1
    Email author
  • the Hiroshima Surgical Study Group of Clinical Oncology
  1. 1.Department of Surgery, Graduate School of Biomedical and Health ScienceHiroshima UniversityHiroshimaJapan
  2. 2.Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health ScienceHiroshima UniversityHiroshimaJapan
  3. 3.Department of SurgeryKure Medical Center and Chugoku Cancer CenterKureJapan
  4. 4.Department of Gastroenterological SurgeryHiroshima City Hiroshima Citizens HospitalHiroshimaJapan
  5. 5.Department of SurgeryHiroshima General HospitalHatsukaichiJapan
  6. 6.Department of SurgeryOnomichi General HospitalOnomichiJapan
  7. 7.Department of SurgeryChugoku Rosai HospitalKureJapan
  8. 8.Department of Gastroenterological SurgeryHiroshima Prefectural HospitalHiroshimaJapan
  9. 9.Department of SurgeryHiroshima City Asa Citizens HospitalHiroshimaJapan
  10. 10.Department of SurgeryHiroshima Memorial HospitalHiroshimaJapan

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