Abstract
Purpose
At present, ≥ 20% of patients experience clinically relevant postoperative pancreatic fistula (POPF) after distal pancreatectomy (DP).
Methods
We developed a new bioabsorbable pancreatic clip (BioPaC) made of polycaprolactone that does not crush the pancreatic parenchyma during occlusion of the pancreatic stump. We confirmed the efficacy of this BioPac in a porcine DP model and compared it to a linear stapling device (Reinforce®).
Results
Pigs were killed at 1 month after DP. In the BioPaC group, all swine (n = 3) survived well without POPF. In the Reinforce® group (n = 2), one pig died early at postoperative day 7 with Grade C POPF (amylase 43 700 U/l), and the other survived until 1 month at scarification with biochemical leakage of POPF (amylase 3 725 U/l). Pathologically, the main pancreatic duct and pancreatic parenchyma were well closed by BioPaC.
Conclusion
The newly developed BioPaC is effective in a porcine DP model.
Similar content being viewed by others
References
Yamashita Y, Taketomi A, Fukuzawa K, Tsujita E, Harimoto N, Kitagawa D, et al. Risk factors for and management of delayed intraperitoneal hemorrhage after pancreatic and biliary surgery. Am J Surg. 2007;193:454–9.
Ratnayake CBB, Wells C, Hammond J, French JJ, Windsor JA, Pandanaboyana S. Network meta-analysis comparing techniques and outcomes of stump closure after distal pancreatectomy. Br J Surg. 2019;106:1580–9.
Nakamura M, Wakabayashi G, Miyasaka Y, Tanaka M, Morikawa T, Unno M, et al; Study Group of JHBPS; JSEPS, Tomiyama Y, Miyata H, Takahara T, Beppu T, Yamaue H, Miyazaki M, Takada T. Multicenter comparative study of laparoscopic and open distal pancreatectomy using propensity score-matching. J Hepatobiliary Pancreat Sci. 22: 731–6, 2015.
Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, et al. Efficacy of stapler vs. hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011;377:1514–22.
Zhang H, Zhu F, Shen M, Tian R, Shi CJ, Wang X, et al. Systematic review and meta-analysis comparing three techniques for pancreatic remnant closure following distal pancreatectomy. Br J Surg. 2015;102:4–15.
Yamashita YI, Tsujita E, Chikamoto A, Imai K, Kaida T, Yamao T, et al. Linear stapling device with pre-attached bioabsorbable polyglycolic acid felt reduces postoperative pancreatic fistula after distal pancreatectomy. Anticancer Res. 2017;37:1865–8.
Ikeda T, Akahoshi T, Kawanaka H, Uchiyama H, Yamashita Y, Morita M, et al. Evaluation of a transection method for distal pancreatectomy: a comparative study on the use of electrosurgical and stapling devices in swine. Fukuoka Igaku Zasshi. 2013;104:515–22.
Zhang W, Wei Z, Che X. Effect of polyglycolic acid mesh for prevention of pancreatic fistula after pancreatectomy: a systematic review and meta-analysis. Medicine (Baltimore). 2020;99:21456.
Kondo N, Uemura K, Nakagawa N, Okada K, Kuroda S, Sudo T, Hiroshima Surgical Study Group of Clinical Oncology, et al. A Multicenter, Randomized, Controlled Trial Comparing Reinforced Staplers with Bare Staplers During Distal Pancreatectomy (HiSCO-07 Trial). Ann Surg Oncol. 2019;26:1519–27.
Matsumoto I, Kamei K, Satoi S, Murase T, Matsumoto M, Kawaguchi K, Yoshida Y, Dongha L, Takebe A, Nakai T, Takeyama Y. Efficacy of the slow firing method using a reinforced triple-row stapler for preventing postoperative pancreatic fistula during laparoscopic distal pancreatectomy. Surg Today. 2021. https://doi.org/10.1007/s00595-021-02344-z.
Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, et al. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005;138:8–13.
Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, et al. The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 years after. Surgery. 2017;161:584–91.
Tsuchitani M, Sato J, Kokoshima H. A comparison of the anatomical structure of the pancreas in experimental animals. J Toxicol Pathol. 2016;29:147–54.
Ferrer J, Scott WE 3rd, Weegman BP, Suszynski TM, Sutherland DE, Hering BJ, et al. Pig pancreas anatomy: implications for pancreas procurement, preservation, and islet isolation. Transplantation. 2008;86:1503–10.
Eguchi H, Nagano H, Tanemura M, Takeda Y, Marubashi S, Kobayashi S, et al. A thick pancreas is a risk factor for pancreatic fistula after a distal pancreatectomy: selection of the closure technique according to the thickness. Dig Surg. 2011;28:50–6.
Kawai M, Tani M, Okada K, Hirono S, Miyazawa M, Shimizu A, et al. Stump closure of a thick pancreas using stapler closure increases pancreatic fistula after distal pancreatectomy. Am J Surg. 2013;206:352–9.
Acknowledgements
We have applied for a PCT patent concerning this work as follows: Baba, H., Yamashita, H., and Ijima, H. inventors; Kumamoto University, and Kyushu University, assignees. Organ Resection Stump Fixing Clip. PCT Application No. PCT/JP2020/011641, filed March 17, 2020. This research was supported by AMED under Grant Number JP18lm0203009 and JP20ml0203112, and Grants-in-Aid for Scientific Research (KAKENHI) under Grant Number 21K19534. This work was supported by the Center for Clinical and Translational Research of Kyushu University and the Kumamoto Innovative Department Organization.
Author information
Authors and Affiliations
Contributions
Conception and design; Yamashita, Ijima, and Baba. Analysis and interpretation; Yamashita, Ijima, and Aishima. Data collection: Yamashita, Yamao, Nakao, Miyata, Ikegami, Yamane, Ito, Furukawa, Cho, Wu, and Ijima. Writing article; Yamashita and Ijima. Critical revision of the article: Baba. Obtaining funding: Yamashita, Arima, Fujie, and Baba.
Corresponding authors
Ethics declarations
Conflict of interest
We have applied for a PCT patent concerning this work as follows: Baba, H., Yamashita, H., and Ijima, H. inventors; Kumamoto University, and Kyushu University, assignees. Organ Resection Stump Fixing Clip. PCT Application No. PCT/JP2020/011641, filed March 17, 2020.
Approval of the research protocol
N/A.
Informed consent
N/A.
Registry and the registration no. of the study/trial
N/A.
Animal study
This study was performed in the Center for Animal Resources and Development of Kumamoto University, and the Kumamoto University Institutional Animal Care and Use Committee approved the animal protocol (A2020-072).
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Yamashita, Yi., Yamao, T., Nakao, Y. et al. Efficacy of a newly developed bioabsorbable pancreatic clip for distal pancreatectomy in swine. Surg Today 52, 1109–1114 (2022). https://doi.org/10.1007/s00595-021-02435-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00595-021-02435-x