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| Segmented biodegradable esophageal stents in a porcine model: preclinical evaluation of degradation, complications and tissue reactions |
CAO Yang1( ),FENG Yadong1,JIAO Chunhua1,SHI Ruihua1,2,*() |
1. Department of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
2. Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing 210009, China |
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Abstract Objective: To evaluate the feasibility of two types of segmented biodegradable esophageal stents in treatment of refractory benign esophagus strictures. Methods: Uncovered biodegradable segmented stent and fully-covered biodegradable segmented stent were implanted into the porcine esophagus (6 for each). Data on biodegradation, complications, and tissue reactions were compared between two groups. Results: All animals kept good general conditions; no death, decreased food intake, weight loss and malnutrition were observed. No perforation, ulcer, hemorrhage, stent migration and severe complications occurred. Stents degradation commenced at week 3. Stents structure breakage and complete stents absorption occurred at week 7-8 and week 9-10 in uncovered stents. While in fully-covered stents, stents structure breakage and complete stents absorption occurred at week 8-9 and week 10-11. Hyperplasia was prominent at week 1-3 and ameliorated at week 6 after stent implantation. A longer degradation period was present in fully-covered stents than in uncovered stents, while fully-covered stents induced tissue reactions at early stage were mild. Conclusions: The application of biodegradable esophageal stents with a segmented trunk in refractory benign esophagus strictures worth further investigation. The fully-covered stent has longer degradation period, which may be more suitable for clinical use.
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Received: 12 May 2017
Published: 25 December 2017
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Corresponding Authors:
SHI Ruihua
E-mail: caoyang@jsph.org.cn;ruihuashi@126.com
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分段式可降解食管支架的临床前评价
目的: 评估分段式无覆膜和全覆膜可降解食管支架应用于难治性良性食管狭窄的可行性。方法: 将无覆膜和全覆膜分段可降解食管支架分别植入巴马猪食管腔内（各6只），每周内镜观察并比较支架降解、支架相关并发症和食管黏膜组织反应。结果: 所有巴马猪健康状态均良好，进食正常，无食欲下降、体质量下降、营养不良和死亡，内镜观察无食管黏膜出血、穿孔、溃疡形成和支架移位发生。两种支架均在第3周开始降解。无覆膜支架在第7~8周出现结构破坏，第9~10周完全降解; 全覆膜支架在第8~9周出现结构破坏，第10~11周完全降解。与无覆膜支架相比，全覆膜支架降解时间较长，支架降解前期黏膜增生组织程度较轻（均P < 0.05）。结论: 分段式可降解食管支架在难治性良性食管狭窄中的应用值得进一步评估。全覆膜支架因具有较长的降解时间，可能更具临床应用优势。
关键词：
食管狭窄/病理学,
支架,
生物降解, 环境,
评价研究,
动物实验
|
|
| [1] |
VAN BOECKEL P G , SIERSEMA P D . Refractory esophageal strictures:what to do when dilation fails[J]. Curr Treat Options Gastroenterol, 2015, 13 (1): 47- 58
doi: 10.1007/s11938-014-0043-6
|
|
|
| [2] |
EISEN G M , BARON T H , DOMINITZ J A et al. Complications of upper GI endoscopy[J]. Gastrointest Endosc, 2002, 55 (7): 784- 793
doi: 10.1016/S0016-5107(02)70404-5
|
|
|
| [3] |
SHAH J N . Benign refractory esophageal strictures:widening the endoscopist's role[J]. Gastrointest Endosc, 2006, 63 (1): 164- 167
doi: 10.1016/j.gie.2005.08.033
|
|
|
| [4] |
HAM Y H , KIM G H . Plastic and biodegradable stents for complex and refractory benign esophageal strictures[J]. Clin Endosc, 2014, 47 (4): 295- 300
doi: 10.5946/ce.2014.47.4.295
|
|
|
| [5] |
VAN BOECKEL P G , VLEGGAAR F P , SIERSEMA P D . A comparison of temporary self-expanding plastic and biodegradable stents for refractory benign esophageal strictures[J]. Clin Gastroenterol Hepatol, 2011, 9 (8): 653- 659
doi: 10.1016/j.cgh.2011.04.006
|
|
|
| [6] |
ELOUBEIDI M A , TALREJA J P , LOPEST L et al. Success and complications associated with placement of fully covered removable self-expandable metal stents for benign esophageal diseases (with videos)[J]. Gastrointest Endosc, 2011, 73 (4): 673- 681
doi: 10.1016/j.gie.2010.11.014
|
|
|
| [7] |
DUA K S , VLEGGAARF P , Santharam R et al. Removable self-expanding plastic esophageal stent as a continuous, non-permanent dilator in treating refractory benign esophageal strictures:a prospective two-center study[J]. Am J Gastroenterol, 2008, 103 (12): 2988- 2994
doi: 10.1111/ajg.2008.103.issue-12
|
|
|
| [8] |
SHARMA P , KOZAREK R . Role of esophageal stents in benign and malignant diseases[J]. Am J Gastroenterol, 2010, 105 (2): 258- 273, 274
doi: 10.1038/ajg.2009.684
|
|
|
| [9] |
REPICI A , HASSAN C , SHARMA P et al. Systematic review:the role of self-expanding plastic stents for benign oesophageal strictures[J]. Aliment Pharmacol Ther, 2010, 31 (12): 1268- 1275
doi: 10.1111/apt.2010.31.issue-12
|
|
|
| [10] |
NOVOTNY L , CRHA M , RAUSER P et al. Novel biodegradable polydioxanone stents in a rabbit airway model[J]. J Thorac Cardiovasc Surg, 2012, 143 (2): 437- 444
doi: 10.1016/j.jtcvs.2011.08.002
|
|
|
| [11] |
National Research Council . Guide for the care and use of laboratory animals[M]. Washingtion DC: Nation Academy Press, 1996.
|
|
|
| [12] |
TANAKA T , TAKAHASHI M , NITTA N et al. Newly developed biodegradable stents for benign gastrointestinal tract stenoses:a preliminary clinical trial[J]. Digestion, 2006, 74 (3-4): 199- 205
doi: 10.1159/000100504
|
|
|
| [13] |
SAITO Y , TANAKA T , ANDOH A et al. Usefulness of biodegradable stents constructed of poly-/-lactic acid monofilaments in patients with benign esophageal stenosis[J]. World J Gastroenterol, 2007, 13 (29): 3977- 80
doi: 10.3748/wjg.v13.i29.3977
|
|
|
| [14] |
SAITO Y , TANAKA T , ANDOH A et al. Novel biodegradable stents for benign esophageal strictures following endoscopic submucosal dissection[J]. Dig Dis Sci, 2008, 53 (2): 330- 333
doi: 10.1007/s10620-007-9873-6
|
|
|
| [15] |
HAIR C S , DEVONSHIRE D A . Severe hyperplastic tissue stenosis of a novel biodegradable esophageal stent and subsequent successful management with high-pressure balloon dilation[J]. Endoscopy, 2010, 42 Suppl 2 E132- E133
|
|
|
| [16] |
ORIVE-CALZADA A , ALVAREZ-RUBIO M , ROMERO-IZQUIERDO S et al. Severe epithelial hyperplasia as a complication of a novel biodegradable stent[J]. Endoscopy, 2009, 41 Suppl 2 E137- E138
|
|
|
| [17] |
CANENA J M , LIBERATO M J , RIO-TINTO R A et al. A comparison of the temporary placement of 3 different self-expanding stents for the treatment of refractory benign esophageal strictures:a prospective multicentre study[J]. BMC Gastroenterol, 2012, 12 70
doi: 10.1186/1471-230X-12-70
|
|
|
| [18] |
CHUNG E , MCPHERSON N , GRANT A . Tensile strength of absorbable suture materials:in vitro analysis of the effects of pH and bacteria[J]. J Surg Educ, 2009, 66 (4): 208- 211
doi: 10.1016/j.jsurg.2009.06.007
|
|
|
| [19] |
REPICI A , VLEGGAAR F P , HASSAN C et al. Efficacy and safety of biodegradable stents for refractory benign esophageal strictures:the BEST (Biodegradable Esophageal Stent) study[J]. Gastrointest Endosc, 2010, 72 (5): 927- 934
doi: 10.1016/j.gie.2010.07.031
|
|
|
| [20] |
KARBOWSKI M , SCHEMBRE D , KOZAREK R et al. Polyflex self-expanding, removable plastic stents:assessment of treatment efficacy and safety in a variety of benign and malignant conditions of the esophagus[J]. Surg Endosc, 2008, 22 (5): 1326- 1333
doi: 10.1007/s00464-007-9644-7
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