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Effect of flowable thrombin-containing collagen-based hemostatic matrix for preventing pancreatic fistula after pancreatectomy: A randomized clinical trial

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AHBPS

Annals of Hepato-Biliary-Pancreatic Surgery

www.ahbps.org S371

Effect of flowable thrombin-containing collagen-based hemostatic matrix for preventing pancreatic fistula after

pancreatectomy: A randomized clinical trial

Yejong PARK

1

, Jae Hyung KO

2

, Dae Ryong KANG

3

, Jun Hyeok LEE

3

, Dae Wook HWANG

1

, Jae Hoon LEE

1

, Woohyung LEE

1

, Jaewoo KWON

1

, Si-Nae PARK

2

, Ki-Byung SONG

1

, Song Cheol KIM*

,1

1

Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine & Asan Medical Center, Seoul, Korea

2

Regenerative Medicine Research Center, Seoul, Korea

3

Department of Precision Medicine, Wonju College of Medicine, Yonsei University, Wonju, Korea

EP-172

Introduction: The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effect for post- operative pancreatic fistula (POPF) after pancreatectomy.

Methods: This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial.

The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay.

Results: This study evaluated a total of 54 patients, with 26 patients in the intervention group (flowable hemostatic matrix) and 27 patients in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy (DP), POPF (33.3% vs. 92.3%, p = 0.004) and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) were more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use ( p = 0.029) as an independent negative risk factor for POPF.

Conclusions: Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatec- tomy, especially for patients with DP.

pISSN: 2508-5778ㆍeISSN: 2508-5859

Ann Hepatobiliary Pancreat Surg 2021;25 Suppl 1:S371 https://doi.org/10.14701/ahbps.EP-172

Corresponding Author: Song Cheol KIM ([email protected]) Presenter: Yejong PARK ([email protected])

Copyright Ⓒ The Korean Association of Hepato-Biliary-Pancreatic Surgery

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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