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

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 I...

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Autores principales: Park, Yejong, Ko, Jae Hyung, Kang, Dae Ryong, Lee, Jun Hyeok, Hwang, Dae Wook, Lee, Jae Hoon, Lee, Woohyung, Kwon, Jaewoo, Park, Si-Nae, Song, Ki-Byung, Kim, Song Cheol
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7601002/
https://www.ncbi.nlm.nih.gov/pubmed/32987876
http://dx.doi.org/10.3390/jcm9103085
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author Park, Yejong
Ko, Jae Hyung
Kang, Dae Ryong
Lee, Jun Hyeok
Hwang, Dae Wook
Lee, Jae Hoon
Lee, Woohyung
Kwon, Jaewoo
Park, Si-Nae
Song, Ki-Byung
Kim, Song Cheol
author_facet Park, Yejong
Ko, Jae Hyung
Kang, Dae Ryong
Lee, Jun Hyeok
Hwang, Dae Wook
Lee, Jae Hoon
Lee, Woohyung
Kwon, Jaewoo
Park, Si-Nae
Song, Ki-Byung
Kim, Song Cheol
author_sort Park, Yejong
collection PubMed
description 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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spelling pubmed-76010022020-11-01 Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial Park, Yejong Ko, Jae Hyung Kang, Dae Ryong Lee, Jun Hyeok Hwang, Dae Wook Lee, Jae Hoon Lee, Woohyung Kwon, Jaewoo Park, Si-Nae Song, Ki-Byung Kim, Song Cheol J Clin Med Article 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. MDPI 2020-09-24 /pmc/articles/PMC7601002/ /pubmed/32987876 http://dx.doi.org/10.3390/jcm9103085 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Park, Yejong
Ko, Jae Hyung
Kang, Dae Ryong
Lee, Jun Hyeok
Hwang, Dae Wook
Lee, Jae Hoon
Lee, Woohyung
Kwon, Jaewoo
Park, Si-Nae
Song, Ki-Byung
Kim, Song Cheol
Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial
title Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial
title_full Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial
title_fullStr Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial
title_full_unstemmed Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial
title_short Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial
title_sort effect of flowable thrombin-containing collagen-based hemostatic matrix for preventing pancreatic fistula after pancreatectomy: a randomized clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7601002/
https://www.ncbi.nlm.nih.gov/pubmed/32987876
http://dx.doi.org/10.3390/jcm9103085
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