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Langenbeck's Archives of Surgery

, Volume 403, Issue 8, pp 933–940 | Cite as

Effect of early administration of coagulation factor XIII on fistula after pancreatic surgery: the FIPS randomized controlled trial

  • Yoshinori Takeda
  • Yoshihiro Mise
  • Naoki Ishizuka
  • Sohei Harada
  • Brian Hayama
  • Yosuke Inoue
  • Takeaki Ishizawa
  • Hiromichi Ito
  • Yu Takahashi
  • Akio SaiuraEmail author
Controlled Clinical Trials
  • 52 Downloads

Abstract

Purpose

The administration of exogenous factor XIII (FXIII) is reportedly effective for fistula closure in patients with a low plasma FXIII level. This study was performed to analyze the effect of early administration of exogenous FXIII on postoperative pancreatic fistula (POPF).

Methods

A single-center randomized controlled, open-label, parallel group, superiority trial was conducted from October 2015 to August 2016 in Japan. Patients with POPF and a plasma FXIII level of ≤ 70% on postoperative day 7 were randomly assigned to an early replacement (ER) group or control group in a 1:1 ratio by an independent coordinator using a computer-generated random number table. The ER group received FXIII concentrate the day after randomization, and the control group received no FXIII concentrate within 2 weeks. The primary endpoint was the duration of drain placement from randomization (DDPR).

Results

Fifty patients were randomized (ER group, 24; control group, 26), and all were analyzed with an intention-to-treat approach. There was no significant difference in the DDPR between the two groups (18 vs. 16 days; hazard ratio, 1.45; 95% confidence interval, 0.813–2.583). No serious harm was reported in either group.

Conclusion

Early administration of exogenous FXIII does not facilitate the healing of POPF.

Trial registration

University Hospital Medical Information Network (UMIN) Center (UMIN000019480, http://www.umin.ac.jp).

Keywords

Postoperative pancreatic fistula Coagulation factor XIII Early cure RCT 

Notes

Data access and responsibility

The principal investigator, Yoshinori Takeda, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Authors’ contributions

The contribution of each author was as follows. YT—conception and design of the study, acquisition of data, and drafting of the manuscript. YM—conception and design of the work and drafting and critical revision of the manuscript. NI—analysis and interpretation of data and critical revision of the manuscript. SH—analysis and interpretation of data AND critical revision of the manuscript. BH—analysis and interpretation of data and critical revision of the manuscript. YI—analysis and interpretation of data and critical revision of the manuscript. TI—analysis and interpretation of data and critical revision of the manuscript. HI—analysis and interpretation of data and critical revision of the manuscript. YT—analysis and interpretation of data and critical revision of the manuscript. AS—analysis and interpretation of data and critical revision of the manuscript.

Compliance with ethical standards

This research involved human participants. Informed consent was obtained from all individual participants included in the present study.

Ethical approval

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institution and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conflict of interest

The authors declare that they have no conflicts of interest.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Yoshinori Takeda
    • 1
    • 2
  • Yoshihiro Mise
    • 1
  • Naoki Ishizuka
    • 3
  • Sohei Harada
    • 4
  • Brian Hayama
    • 4
  • Yosuke Inoue
    • 1
  • Takeaki Ishizawa
    • 1
  • Hiromichi Ito
    • 1
  • Yu Takahashi
    • 1
  • Akio Saiura
    • 1
  1. 1.Department of Hepatobiliary-Pancreatic Surgery, Japanese Foundation for Cancer ResearchCancer Institute HospitalTokyoJapan
  2. 2.Department of Hepatobiliary-Pancreatic SurgeryJuntendo University School of MedicineTokyoJapan
  3. 3.Clinical Research and Medical Development Center, Japanese Foundation for Cancer ResearchCancer Institute HospitalTokyoJapan
  4. 4.Department of Infectious Diseases, Japanese Foundation for Cancer ResearchCancer Institute HospitalTokyoJapan

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