Chang-Il Kwon1, Jun Sik Son2, Kyu Seok Kim3, Jong Pil Moon3, Sehwan Park3, Jinkyung Jeon3, Gwangil Kim4, Sung Hoon Choi1, Kwang Hyun Ko1, Seok Jeong5, Don Haeng Lee5. 1. Digestive Disease Center, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea. 2. Korea Textile Development Institute, Daegu, Republic of Korea. 3. Interventional Research Center, M.I.Tech, Co. Ltd, Pyeongtaek, Republic of Korea. 4. Department of Pathology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea. 5. Division of Gastroenterology, Department of Internal Medicine, Inha University College of Medicine, T2B Infrastructure Center for Digestive Disorders, Incheon, Republic of Korea.
Abstract
OBJECTIVES: The clinical outcomes and prevalence of adverse events associated with biliary biodegradable stents (BS) can differ according to degradation process and time. The aim of this study was to observe the degradation process and time of different BS prototypes, and to evaluate sequential changes in their mechanical properties. METHODS: Using an in vitro bile flow phantom model, we compared degradation time, radial force changes, and morphologic changes among four different BS prototypes: polydioxanone (PDO) BS, polyglycolide (PGA) BS, polydioxanone/poly-L-lactic acid (PDO/PLLA) sheath core BS, and polydioxaone/magnesium (PDO/Mg) sheath core BS. Using an in vivo swine bile duct dilation model, we performed a direct peroral cholangioscopy (DPOC) examination to observe the biodegradation process and related adverse events at regular intervals. RESULTS: In the bile flow phantom model, the PGA BS and PDO/Mg BS prototypes showed rapid radial force reduction and morphological changes and complete degradation within six weeks. PDO/PLLA BS maintained high radial force and kept their original shape for longer than the PDO BS, up to 16 weeks. A total of 24 BS were inserted into the dilated bile ducts of 12 swine. In this animal model, DPOC examination revealed that PDO BS and PDO/PLLA BS maintained their original shapes for approximately 12 weeks, but PDO BS showed a greater degree of fragmentation and induced biliary stones and bile duct obstruction. CONCLUSION: Our results showed that PDO/PLLA BS maintained their original shape and radial force for a relatively long time and minimized adverse events. This article is protected by copyright. All rights reserved.
OBJECTIVES: The clinical outcomes and prevalence of adverse events associated with biliary biodegradable stents (BS) can differ according to degradation process and time. The aim of this study was to observe the degradation process and time of different BS prototypes, and to evaluate sequential changes in their mechanical properties. METHODS: Using an in vitro bile flow phantom model, we compared degradation time, radial force changes, and morphologic changes among four different BS prototypes: polydioxanone (PDO) BS, polyglycolide (PGA) BS, polydioxanone/poly-L-lactic acid (PDO/PLLA) sheath core BS, and polydioxaone/magnesium (PDO/Mg) sheath core BS. Using an in vivo swine bile duct dilation model, we performed a direct peroral cholangioscopy (DPOC) examination to observe the biodegradation process and related adverse events at regular intervals. RESULTS: In the bile flow phantom model, the PGA BS and PDO/Mg BS prototypes showed rapid radial force reduction and morphological changes and complete degradation within six weeks. PDO/PLLA BS maintained high radial force and kept their original shape for longer than the PDO BS, up to 16 weeks. A total of 24 BS were inserted into the dilated bile ducts of 12 swine. In this animal model, DPOC examination revealed that PDO BS and PDO/PLLA BS maintained their original shapes for approximately 12 weeks, but PDO BS showed a greater degree of fragmentation and induced biliary stones and bile duct obstruction. CONCLUSION: Our results showed that PDO/PLLA BS maintained their original shape and radial force for a relatively long time and minimized adverse events. This article is protected by copyright. All rights reserved.
Authors: Chang-Il Kwon; Sung Hoon Choi; Kyu Seok Kim; Jong Pil Moon; Sehwan Park; Jinkyung Jeon; Gwangil Kim; Jae Young Jang; Min Je Sung; Kwang Hyun Ko; Jun Sik Son Journal: Ann Surg Treat Res Date: 2022-02-04 Impact factor: 1.859