Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Sep 24;9(10):3085.
doi: 10.3390/jcm9103085.

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   4 , 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   5
Affiliations

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

Yejong Park et al. J Clin Med. .

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.

Keywords: pancreatectomy; pancreatic fistula; pancreatic neoplasm.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Preparation of CollaStat®. (A) CollaStat consists of two syringes: one for collagen granules and thrombin and the other for CaCl2 solution. (B) CollaStat® can be easily prepared by connecting the two syringes and mixing them. (C) After mixing and detaching the CaCl2 syringe, CollaStat is ready for use by connecting the enclosed application tip.
Figure 2
Figure 2
CONSORT flow diagram of the trial.
See this image and copyright information in PMC

References

    1. Kimura W., Miyata H., Gotoh M., Hirai I., Kenjo A., Kitagawa Y., Shimada M., Baba H., Tomita N., Nakagoe T., et al. A Pancreaticoduodenectomy Risk Model Derived From 8575 Cases From a National Single-Race Population (Japanese) Using a Web-Based Data Entry System The 30-Day and In-hospital Mortality Rates for Pancreaticoduodenectomy. Ann. Surg. 2014;259:773–780. doi: 10.1097/SLA.0000000000000263. - DOI - PubMed
    1. Sakaguchi T., Nakamura S., Suzuki S., Kojima Y., Tsuchiya Y., Konno H., Nakaoka J., Nishiyama R. Marginal ulceration after pylorus-preserving pancreaticoduodenectomy. J. Hepatobiliary Pancreat. Surg. 2000;7:193–197. doi: 10.1007/s005340050175. - DOI - PubMed
    1. Lillemoe K.D., Kaushal S., Cameron J.L., Sohn T.A., Pitt H.A., Yeo C.J. Distal pancreatectomy: Indications and outcomes in 235 patients. Ann. Surg. 1999;229:693–698; discussion 698–700. doi: 10.1097/00000658-199905000-00012. - DOI - PMC - PubMed
    1. Song K.B., Kim S.C., Hwang D.W., Lee J.H., Lee D.J., Lee J.W., Park K.M., Lee Y.J. Matched Case-Control Analysis Comparing Laparoscopic and Open Pylorus-preserving Pancreaticoduodenectomy in Patients With Periampullary Tumors. Ann. Surg. 2015;262:146–155. doi: 10.1097/SLA.0000000000001079. - DOI - PubMed
    1. Knaebel H.P., Diener M.K., Wente M.N., Buchler M.W., Seiler C.M. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br. J. Surg. 2005;92:539–546. doi: 10.1002/bjs.5000. - DOI - PubMed

LinkOut - more resources