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The Effect of Fibrinogen/Thrombin-Coated Collagen Patch (TachoSil®) Application in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreaticoduodenectomy: A Randomized Clinical Trial

  • Jaewoo Kwon
  • Sang Hyun Shin
  • Sukyung Lee
  • Guisuk Park
  • Yejong Park
  • Seung Jae Lee
  • Woohyung Lee
  • Ki Byung Song
  • Dae Wook Hwang
  • Song Cheol Kim
  • Jae Hoon LeeEmail author
Original Scientific Report
  • 39 Downloads

Abstract

Background

Fibrin sealants and topical glue have been studied to reduce the incidence of postoperative pancreatic fistulas (POPF) after pancreatico-enteric anastomosis, but a definitive innovation is still needed. We aim to evaluate the effectiveness of fibrin sealant patch applied to pancreatico-enteric anastomosis to reduce postoperative complications, including POPF.

Methods

This study was a single-center, prospective, randomized, phase IV trial involving three pancreaticobiliary surgeons. The primary outcome was POPF; secondary outcomes included complications, drain removal days, hospital stay, readmission rate, and cost. Risk factors for POPF were identified by logistic regression analysis.

Results

A total of 124 patients were enrolled. Biochemical leakage (BL) or POPF occurred in 16 patients (25.8%) in the intervention group and 23 patients (37.1%) in the control group (no statistical significance). Clinically relevant POPF occurred in 4 patients (6.5%) in both the intervention and control groups (p = 1.000). Hospital stay (11.6 days vs. 12.1 days, p = 0.585) and drain removal days (5.7 days vs. 5.3 days, p = 0.281) were not statistically different between two groups. Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103). In multivariable analysis, age and soft pancreas texture were independent risk factors for BL or POPF in this study. Applying fibrin sealant patch is not a negative risk factor, but the p value may indicate a likelihood of reducing the incidence of BL (p = 0.084).

Conclusions

Fibrin sealant patches after pancreaticojejunostomy did not reduce the incidence of POPF or other postoperative complications. This study was registered at clinicaltrials.gov (NCT03269955).

Notes

Acknowledgements

This study was supported by a grant from Asan Institute for Life Science.

Compliance with ethical standards

Conflict of interest

The authors declare no competing interests in relation to this study.

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Copyright information

© Société Internationale de Chirurgie 2019

Authors and Affiliations

  • Jaewoo Kwon
    • 1
  • Sang Hyun Shin
    • 2
  • Sukyung Lee
    • 1
  • Guisuk Park
    • 1
  • Yejong Park
    • 1
  • Seung Jae Lee
    • 1
  • Woohyung Lee
    • 1
  • Ki Byung Song
    • 1
  • Dae Wook Hwang
    • 1
  • Song Cheol Kim
    • 1
  • Jae Hoon Lee
    • 1
    Email author
  1. 1.Division of Hepato-Biliary and Pancreatic Surgery, Department of SurgeryUniversity of Ulsan College of Medicine and Asan Medical CenterSeoulSouth Korea
  2. 2.Division of Hepatobiliary-Pancreatic Surgery, Department of Surgery, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulSouth Korea

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