Clinical Endoscopy

The Korean Society of Gastrointestinal Endoscopy (대한소화기내시경학회)
권호 표지
DOI QR코드

DOI QR Code

Evaluation of the mechanical properties of current biliary selfexpandable metallic stents: axial and radial force, and axial force zero border

  • Wataru Yamagata (Department of Gastroenterology, Graduate School of Medicine, Juntendo University) ;
  • Toshio Fujisawa (Department of Gastroenterology, Graduate School of Medicine, Juntendo University) ;
  • Takashi Sasaki (Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research) ;
  • Rei Ishibashi (Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo) ;
  • Tomotaka Saito (Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo) ;
  • Shuntaro Yoshida (Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo) ;
  • Shizuka No (Medical Laboratory, Research & Development Center, Zeon Corporation) ;
  • Kouta Inoue (Medical Laboratory, Research & Development Center, Zeon Corporation) ;
  • Yousuke Nakai (Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo) ;
  • Naoki Sasahira (Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research) ;
  • Hiroyuki Isayama (Department of Gastroenterology, Graduate School of Medicine, Juntendo University)
  • Received : 2022.07.25
  • Accepted : 2022.09.27
  • Published : 2023.09.30
Download PDF
⟨ Previous Next ⟩

Abstract

Background/Aims: Mechanical properties (MPs) and axial and radial force (AF and RF) may influence the efficacy and complications of self-expandable metallic stent (SEMS) placement. We measured the MPs of various SEMSs and examined their influence on the SEMS clinical ability. Methods: We evaluated the MPs of 29 types of 10-mm SEMSs. RF was measured using a conventional measurement device. AF was measured using the conventional and new methods, and the correlation between the methods was evaluated. Results: A high correlation in AFs was observed, as measured by the new and conventional manual methods. AF and RF scatterplots divided the SEMSs into three subgroups according to structure: hook-and-cross-type (low AF and RF), cross-type (high AF and low RF), and laser-cut-type (intermediate AF and high RF). The hook-and-cross-type had the largest axial force zero border (>20°), followed by the laser-cut and cross types. Conclusions: MPs were related to stent structure. Hook-and-cross-type SEMSs had a low AF and high axial force zero border and were considered safest because they caused minimal stress on the biliary wall. However, the increase in RF must be overcome.

Keywords

Acknowledgement

This in vitro study was conducted at the Medical Laboratory, Research and Development Center, Zeon Corporation, Toyama, Japan. We thank the Zeon Corporation for access to the measurement system used in this study. The staff of Zeon Medical Inc. and Zeon Corporation (Nobukazu Nishimura, Tetsuji Shimono, Takuya Kagoshima, Atsushi Yasunaka, Koichi Inoue, Kou Kayukawa, Hiromi Mizoroki, Hiroki Shinagawa, and Chimyon Gon) supported this study (the data interpretation and preparation of this paper were performed by doctors). We also express our sincere appreciation to the manufacturers and distributors for providing the SEMSs used in this study, including BCM Co. Ltd, Boston Scientific Corporation, Century Medical Inc., Cook Medical, M.I. TECH. Co. Ltd., Olympus Medical Systems, Piolax Inc., S&G Biotech Inc., Sumitomo Bakelite Co. Ltd., Taewoong Medical Co. Ltd., and Zeon Medical Inc.

References

  1. Conio M, Mangiavillano B, Caruso A, et al. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc 2018;88:283-291.
  2. Sawas T, Al Halabi S, Parsi MA, et al. Self-expandable metal stents versus plastic stents for malignant biliary obstruction: a meta-analysis. Gastrointest Endosc 2015;82:256-267.
  3. Lam R, Muniraj T. Fully covered metal biliary stents: a review of the literature. World J Gastroenterol 2021;27:6357-6373.
  4. Kitagawa K, Mitoro A, Ozutsumi T, et al. Laser-cut-type versus braided-type covered self-expandable metallic stents for distal biliary obstruction caused by pancreatic carcinoma: a retrospective comparative cohort study. Clin Endosc 2022;55:434-442.
  5. Isayama H, Mukai T, Itoi T, et al. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. Gastrointest Endosc 2012;76:84-92.
  6. Saito H, Sakurai Y, Takamura A, et al. [Biliary endoprosthesis using Gore-Tex covered expandable metallic stents: preliminary clinical evaluation]. Nihon Igaku Hoshasen Gakkai Zasshi 1994;54:180-182.
  7. Hori Y, Hayashi K, Yoshida M, et al. Novel characteristics of traction force in biliary self-expandable metallic stents. Dig Endosc 2017;29:347-352.
  8. U.S. Department of Health and Human Services, Food and Drug Administration. Center for Devices and Radiological Health. Metal expandable biliary stents: premarket notification (510(k)) submissions. Silver Spring: Center for Drug Evaluation and Research; 2019.
  9. Isayama H, Nakai Y, Toyokawa Y, et al. Measurement of radial and axial forces of biliary self-expandable metallic stents. Gastrointest Endosc 2009;70:37-44.
  10. Katsinelos P, Lazaraki G, Gkagkalis S, et al. A fully covered self-expandable metal stent anchored by a 10-Fr double pigtail plastic stent: an effective anti-migration technique. Ann Gastroenterol 2017;30:114-117.
  11. Isayama H, Nakai Y, Hamada T, et al. Understanding the mechanical forces of self-expandable metal stents in the biliary ducts. Curr Gastroenterol Rep 2016;18:64.
  12. Nakai Y, Isayama H, Kawakubo K, et al. Metallic stent with high axial force as a risk factor for cholecystitis in distal malignant biliary obstruction. J Gastroenterol Hepatol 2014;29:1557-1562.
  13. Jang S, Stevens T, Parsi M, et al. Association of covered metallic stents with cholecystitis and stent migration in malignant biliary stricture. Gastrointest Endosc 2018;87:1061-1070.
  14. Kawakubo K, Isayama H, Nakai Y, et al. Risk factors for pancreatitis following transpapillary self-expandable metal stent placement. Surg Endosc 2012;26:771-776.
  15. Takeda T, Sasaki T, Mie T, et al. Novel risk factors for recurrent biliary obstruction and pancreatitis after metallic stent placement in pancreatic cancer. Endosc Int Open 2020;8:E1603-E1610.
  16. Nakai Y, Isayama H, Kogure H, et al. Risk factors for covered metallic stent migration in patients with distal malignant biliary obstruction due to pancreatic cancer. J Gastroenterol Hepatol 2014;29:1744-1749.
  17. Sasaki T, Ishibashi R, Yoshida S, et al. Comparing the mechanical properties of a self-expandable metallic stent for colorectal obstruction: proposed measurement method of axial force using a new measurement machine. Dig Endosc 2021;33:170-178.
  18. Rodrigues-Pinto E, Morais R, Sousa-Pinto B, et al. Development of an online app to predict post-endoscopic retrograde cholangiopancreatography adverse events using a single-center retrospective cohort. Dig Dis 2021;39:283-293.
  19. Ida Bagus B. A rare clinical presentation of third part duodenal perforation due to post-endoscopic retrograde cholangiopancreatography stent migration on advanced stage peri-ampullary tumor. JGH Open 2021;5:968-970.
  20. Mukai T, Yasuda I, Isayama H, et al. Comparison of axial force and cell width of self-expandable metallic stents: which type of stent is better suited for hilar biliary strictures? J Hepatobiliary Pancreat Sci 2011;18:646-652.
  21. Weaver M, Lang G, Das K, et al. Metal biliary stent erosion through the common bile duct leading to obstructive jaundice and cholangitis. Am J Gastroenterol 2021;116:1372.