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10.3390/jcm14030764
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Efficacy of a Novel Dual-Layer Plastic Stents for Malignant Biliary Obstruction

by
Masanari Sekine
1,*,
Masashi Ijima
2,
Satoaki Noguchi
2,
Eishin Kurihara
2,
Tsutomu Kobatake
2,
Taku Mizutani
1,
Ryo Hashimoto
1,
Kayoko Aoyama
1,
Goya Sasaki
1,
Azumi Sato
1,
Shu Kojima
1 and
Hirosato Mashima
1
1
Department of Gastroenterology, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan
2
Department of Gastroenterology, Ota Memorial Hospital, Gunma 373-8585, Japan
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2025, 14(3), 764; https://doi.org/10.3390/jcm14030764
Submission received: 30 December 2024 / Revised: 16 January 2025 / Accepted: 20 January 2025 / Published: 24 January 2025
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
Review Reports Versions Notes

Abstract

Objectives: In hepatopancreatic diseases, stenting is widely employed to manage cholangitis and obstructive jaundice. Stent materials are primarily categorized as plastic or metal. Plastic stents have notable advantages, such as reduced likelihood of peripheral bile duct obstruction, a lower cost, and the ease of replacement compared to metallic stents. However, their patency period is shorter due to narrower diameters. Plastic stents are typically composed of materials like polyurethane or polyethylene. To improve patency, new dual-layer stents combine polyurethane with polytetrafluoroethylene (PTFE). PTFE, used in the inner layer, is expected to prevent biofilm formation. This study aimed to assess the clinical efficacy of this dual-layer stent. Methods: A retrospective analysis was performed on 48 cases (Group R) using REGULUS® from November 2022 to November 2023 and 30 cases (Group IS) using inside-type plastic stents from January 2020 to November 2023 for malignant hilar and intrahepatic bile duct obstructions. Stent patency and clinical outcomes were compared between the groups. Results: There was no significant difference in the recurrent biliary obstruction (RBO) rate between the groups (p = 0.644). The time to recurrent biliary obstruction (TRBO) was 74 days in Group R and 118 days in Group IS, with no significant difference (p = 0.219). Conclusions: The dual-layer stent placed across the papilla demonstrated comparable clinical outcomes to inside-type stents. The PTFE inner layer likely reduces biofilm formation, enhancing patency. Across-the-papilla placement may facilitate reinterventions in challenging cases, broadening stent options.
Keywords: plastic stent; malignant biliary obstruction; polytetrafluoroethylene (PTFE) plastic stent; malignant biliary obstruction; polytetrafluoroethylene (PTFE)

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MDPI and ACS Style

Sekine, M.; Ijima, M.; Noguchi, S.; Kurihara, E.; Kobatake, T.; Mizutani, T.; Hashimoto, R.; Aoyama, K.; Sasaki, G.; Sato, A.; et al. Efficacy of a Novel Dual-Layer Plastic Stents for Malignant Biliary Obstruction. J. Clin. Med. 2025, 14, 764. https://doi.org/10.3390/jcm14030764

AMA Style

Sekine M, Ijima M, Noguchi S, Kurihara E, Kobatake T, Mizutani T, Hashimoto R, Aoyama K, Sasaki G, Sato A, et al. Efficacy of a Novel Dual-Layer Plastic Stents for Malignant Biliary Obstruction. Journal of Clinical Medicine. 2025; 14(3):764. https://doi.org/10.3390/jcm14030764

Chicago/Turabian Style

Sekine, Masanari, Masashi Ijima, Satoaki Noguchi, Eishin Kurihara, Tsutomu Kobatake, Taku Mizutani, Ryo Hashimoto, Kayoko Aoyama, Goya Sasaki, Azumi Sato, and et al. 2025. "Efficacy of a Novel Dual-Layer Plastic Stents for Malignant Biliary Obstruction" Journal of Clinical Medicine 14, no. 3: 764. https://doi.org/10.3390/jcm14030764

APA Style

Sekine, M., Ijima, M., Noguchi, S., Kurihara, E., Kobatake, T., Mizutani, T., Hashimoto, R., Aoyama, K., Sasaki, G., Sato, A., Kojima, S., & Mashima, H. (2025). Efficacy of a Novel Dual-Layer Plastic Stents for Malignant Biliary Obstruction. Journal of Clinical Medicine, 14(3), 764. https://doi.org/10.3390/jcm14030764

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