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Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial

Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, University of Ulsan College of Medicine & Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea. Regenerative Medicine Research Center, Dalim Tissen Co., Ltd., 31, Yeonhui-ro, Mapo-gu, Seoul 05505, Korea. Department of Precision Medicine, Wonju College of Medicine, Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do 26493, Korea. Department of Biostatistics, Wonju College of Medicine, Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do 26493, Korea. Asan Medical Institute of Convergence Science and Technology (AMIST), 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.

Journal of clinical medicine. 2020;9(10)
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Abstract
BACKGROUND The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effects for postoperative 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 53 patients, of whom 26 patients were in the intervention group (flowable hemostatic matrix) and 27 patients were 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, POPF (33.3% vs. 92.3%, p = 0.004), and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) was more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use as an independent negative risk factor for POPF, especially in cases of distal pancreatectomy (DP) (odds ratio 17.379, 95% confidential interval 1.453-207.870, p = 0.024). CONCLUSION Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP. Non-inferiority was demonstrated in the efficacy of preventing POPF in the intervention group compared to the control group.
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Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine