Biodegradable stents

生物可降解支架
  • 文章类型: Journal Article
    使用支架的血管内治疗(EVT)已成为严重脑血管狭窄的主要选择。然而,仍有相当大的挑战有待解决,如支架内再狭窄(ISR)和晚期血栓形成。已经开发了许多改良的支架来抑制血管平滑肌细胞(SMC)的过度增殖和保护血管内皮细胞(VEC),从而减少这种并发症。一些改良的支架,比如那些注入雷帕霉素的,在预防急性血栓形成方面有所改善。然而,ISR和晚期血栓形成,这是长期的并发症,仍然不可避免。三七总皂苷(PNS),由各种化合物组成的中药,有利于促进VECs的增殖和迁移,抑制SMCs的增殖。在这里,基于先前的研究,开发了一种装载有PNS的3D打印聚己内酯(PCL)支架(PNS-PCL支架)。体外研究证实,PNS促进VECs的迁移和增殖,被损坏了,通过增加microRNA-126,p-AKT的表达水平,和内皮型一氧化氮合酶.在体内,PNS-PCL支架维持兔颈动脉通畅长达3个月,性能优于PCL支架。PNS-PCL支架可能为脑血管粥样硬化性狭窄的EVT提供新的解决方案。
    Endovascular treatment (EVT) using stents has become the primary option for severe cerebrovascular stenosis. However, considerable challenges remain to be addressed, such as in-stent restenosis (ISR) and late thrombosis. Many modified stents have been developed to inhibit the hyperproliferation of vascular smooth muscle cells (SMCs) and protect vascular endothelial cells (VECs), thereby reducing such complications. Some modified stents, such as those infused with rapamycin, have improved in preventing acute thrombosis. However, ISR and late thrombosis, which are long-term complications, remain unavoidable. Panax notoginseng saponin (PNS), a traditional Chinese medicine consisting of various compounds, is beneficial in promoting the proliferation and migration of VECs and inhibiting the proliferation of SMCs. Herein, a 3D-printed polycaprolactone (PCL) stent loaded with PNS (PNS-PCL stent) was developed based on a previous study. In vitro studies confirmed that PNS promotes the migration and proliferation of VECs, which were damaged, by increasing the expression levels of microRNA-126, p-AKT, and endothelial nitric oxide synthase. In vivo, the PNS-PCL stents maintained the patency of the carotid artery in rabbits for up to three months, outperforming the PCL stents. The PNS-PCL stents may present a new solution for the EVT of cerebrovascular atherosclerotic stenosis in the future.
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  • 文章类型: Journal Article
    目的:利用新型组织病理学评分系统和声门下狭窄(SGS)兔模型,我们的目的是比较两种微创治疗方式之间的声门下炎症程度和狭窄的严重程度:内镜下球囊扩张术(EBD)和EBD单独放置生物可吸收超高延展性镁(UHD-Mg)合金支架.
    方法:通过微悬浮喉镜对23只新西兰大白兔进行内窥镜诱导SGS。对照组(n=11)仅接受EBD,研究组(n=12)接受了EBD,并植入了生物可吸收的UHD-Mg合金支架。兔子在2-,3-,SGS诱导后6周,与伤口愈合阶段相吻合。使用光学相干断层扫描(OCT),比较气道横截面积以计算连续时间点的管腔内面积的平均百分比.一种新颖的组织病理学评分系统用于分析喉气管复合体的冷冻切片。炎症程度通过炎症细胞浸润的评分变化来量化,上皮性溃疡/上皮化生,上皮下水肿/纤维化,和毛细管数/扩张。利用单变量分析来分析这些标志物。
    结果:我们发现植入生物可吸收UHD-Mg合金支架的兔子在增生性变化类别中具有统计学上显着的更高得分(支架与对照:1.48vs0.46p<0.001),鳞状上皮化生(22vs5p<0.001),和腔内的中性粒细胞/纤维蛋白(31vs8,p<0.001)。单独接受EBD的兔上皮下水肿和纤维化评分更高(2.70vs3.49,p<0.0256)。与2周时的对照组相比,支架兔显示出管腔内平均面积的平均狭窄百分比显着增加(88.56vs58.98,p=0.032),然而,在所有其他时间点,腔内声门下狭窄的平均狭窄面积百分比没有显着差异。
    结论:用UHD-Mg合金支架治疗的SGS兔表现出组织病理学结果提示气管纤维化水平较低。与单独的EBD相比,这可能表明狭窄发展的趋势降低。在六周结束时,支架和非支架兔之间的管腔大小没有差异。组织学上,然而,总体而言,使用可生物吸收的UHD-Mg合金支架在表面粘膜水平引起更大的组织反应,而不是在支架兔中看到的固有层纤维化。这表明更有利的愈合和更少的纤维化和狭窄的倾向,即使在该早期愈合期间从管腔尺寸的观点来看可能没有益处。与目前可用的非生物可吸收金属或硅酮基支架的已知并发症相比,这项概念验证研究强调了新型可生物降解UHD-Mg支架作为儿科SGS治疗方式的潜在用途.
    OBJECTIVE: Utilizing a novel histopathological scoring system and subglottic stenosis (SGS) rabbit model, we aimed to compare degrees of inflammation and severity of narrowing in the subglottis between two minimally invasive therapeutic modalities: endoscopic balloon dilation (EBD) alone versus EBD with placement of a bioabsorbable ultra-high ductility magnesium (UHD-Mg) alloy stent.
    METHODS: SGS was induced endoscopically via microsuspension laryngoscopy in 23 New Zealand white rabbits. The control group (n = 11) underwent EBD alone, the study arm (n = 12) underwent EBD with implantation of bioabsorbable UHD-Mg alloy stents. Rabbits were euthanized at 2-, 3-, and 6-weeks after SGS induction, coinciding with wound healing stages. Using Optical Coherence Tomography (OCT), cross-sectional areas of airways were compared to calculate the mean percentage of intraluminal area at sequential time points. A novel histopathological scoring system was used to analyze frozen sections of laryngotracheal complexes. The degree of inflammation was quantified by scoring changes in inflammatory cell infiltration, epithelial ulceration/metaplasia, subepithelial edema/fibrosis, and capillary number/dilation. Univariate analysis was utilized to analyze these markers.
    RESULTS: We found rabbits implanted with the bioabsorbable UHD-Mg alloy stent had statistically significantly higher scores in categories of hyperplastic change (stents vs controls: 1.48 vs 0.46 p < 0.001), squamous metaplasia (22 vs 5 p < 0.001), and neutrophils/fibrin in lumen (31 vs 8, p < 0.001). Rabbits who received EBD alone had higher scores of subepithelial edema and fibrosis (2.70 vs 3.49, p < 0.0256). The stented rabbits demonstrated significantly increased mean percent stenosis by intraluminal mean area compared to controls at 2 weeks (88.56 vs 58.98, p = 0.032), however at all other time points there was no significant difference between intraluminal subglottic stenosis by mean percent stenosis area.
    CONCLUSIONS: Rabbits with SGS treated with UHD-Mg alloy stents demonstrated histopathologic findings suggestive of lower levels of tracheal fibrosis. This could indicate a reduced tendency towards the development of stenosis when compared to EBD alone. There was not a difference in luminal size between stent and non-stented rabbits at the six-week end point. Histologically, however, overall the use of bioabsorbable UHD-Mg alloy stenting elicited a greater tissue response at the level of the superficial mucosa rather than fibrosis of the lamina propria seen in the stented rabbits. This suggests more favorable healing and less of a tendency towards fibrosis and stenosis even though there may not be a benefit from a luminal size standpoint during this early healing period. Compared to known complications of currently available non-bioabsorbable metal or silicone-based stents, this proof-of-concept investigation highlights the potential use of a novel biodegradable UHD-Mg stent as a therapeutic modality for pediatric SGS.
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  • 文章类型: Journal Article
    生物可降解支架已被认为是脑血管疾病的血管内治疗(EVT)的有希望的策略。生物可降解支架的可视化在植入和长期随访中具有重要意义。赋予可生物降解的支架X射线射线不透性可以克服聚合物固有的射线不透性的弱点。因此,这项工作的重点是开发一种完全X射线可见的生物可降解支架(PCL-KIO3),该支架由聚己内酯(PCL)和碘酸钾通过物理混合和3D打印用于脑血管应用。将PCL-KIO3支架植入兔颈动脉,评价其体内成像性能和生物安全性。体外X射线成像结果表明,碘酸钾的引入使3D打印的PCL支架在X射线下可视化。到目前为止,关于体内聚合物支架可视化的研究不足。因此,将完全X线可见的支架植入兔颈动脉,以评估生物安全性和能见度表现.在支架展开的过程中,PCL-KIO3支架的可视化可有效帮助我们了解支架的位置和扩张状态。在6个月的随访中,PCL-KIO3支架在X射线下仍可观察到,并保持了良好的血管通畅性。总而言之,这项研究表明,PCL-KIO3支架可能为生物可降解支架可视化提供稳健的策略.本文受版权保护。保留所有权利。
    Biodegradable stents are considered a promising strategy for the endovascular treatment of cerebrovascular diseases. The visualization of biodegradable stents is of significance during the implantation and long-term follow-up. Endowing biodegradable stents with X-ray radiopacity can overcome the weakness of intrinsic radioparency of polymers. Hence, this work focuses on the development of an entirely X-ray visible biodegradable stent (PCL-KIO3) composed of polycaprolactone (PCL) and potassium iodate via physical blending and 3D printing. The in vitro results show that the introduction of potassium iodate makes the 3D-printed PCL stents visualizable under X-ray. So far, there is inadequate study about polymeric stent visualization in vivo. Therefore, PCL-KIO3 stents are implanted into the rabbit carotid artery to evaluate the biosafety and visibility performance. During stent deployment, the visualization of the PCL-KIO3 stent effectively helps to understand the position and dilation status of stents. At 6-month follow-up, the PCL-KIO3 stent could still be observed under X-ray and maintains excellent vessel patency. To sum up, this study demonstrates that PCL-KIO3 stent may provide a robust strategy for biodegradable stent visualization.
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  • 文章类型: Journal Article
    人体包括在不同的身体系统中具有基本功能的各种管状结构。这些结构负责运送食物,液体,废物,和其他物质在整个身体。然而,炎症等因素,肿瘤,石头,感染,或者物质的积累会导致这些管状结构的变窄或堵塞,会损害相应器官或组织的正常功能。为了解决管腔阻塞,支架是一种常用的治疗方法。然而,为了最大限度地减少与长期植入永久性支架相关的并发症,对生物可降解支架(BDS)的需求不断增加。镁(Mg)金属是创建BDS的一个特殊的选择,由于其降解性,良好的机械性能,和生物相容性。目前,Magmaris®冠状动脉支架和UNITY-BTM胆道支架已获得ConformitéEuropéene(CE)认证。此外,还有其他几种类型的支架正在进行研究和开发以及临床试验。在这次审查中,我们讨论了所需的降解周期和特定特性(抗炎作用,抗菌作用,等。)基于当前可用的镁基支架的生物相容性和可降解性,在不同管腔区域中的BDS。我们还提供有关BDS未来发展的潜在见解。
    The human body comprises various tubular structures that have essential functions in different bodily systems. These structures are responsible for transporting food, liquids, waste, and other substances throughout the body. However, factors such as inflammation, tumors, stones, infections, or the accumulation of substances can lead to the narrowing or blockage of these tubular structures, which can impair the normal function of the corresponding organs or tissues. To address luminal obstructions, stenting is a commonly used treatment. However, to minimize complications associated with the long-term implantation of permanent stents, there is an increasing demand for biodegradable stents (BDS). Magnesium (Mg) metal is an exceptional choice for creating BDS due to its degradability, good mechanical properties, and biocompatibility. Currently, the Magmaris® coronary stents and UNITY-BTM biliary stent have obtained Conformité Européene (CE) certification. Moreover, there are several other types of stents undergoing research and development as well as clinical trials. In this review, we discuss the required degradation cycle and the specific properties (anti-inflammatory effect, antibacterial effect, etc.) of BDS in different lumen areas based on the biocompatibility and degradability of currently available magnesium-based scaffolds. We also offer potential insights into the future development of BDS.
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  • 文章类型: Journal Article
    铁是一种很有前途的心血管支架材料,然而,低生物降解率提出了挑战。这里,据报道,一种动态方法可以提高铁的降解速率,同时提供可能抑制设备上细胞增殖的电能。其通过在基于细胞培养基的电解质中将铁与生物相容性水凝胶阴极配对来实现,从而形成铁-空气电池。该系统在21天的时间内不显示对人脂肪干细胞的细胞毒性,但抑制细胞增殖。通过这种动态方法增强铁降解和抑制细胞增殖的组合表明,它可能是一种抑制可生物降解支架再狭窄的方法。
    Iron is a promising material for cardiovascular stent applications, however, the low biodegradation rate presents a challenge. Here, a dynamic method to improve the degradation rate of iron and simultaneously deliver electrical energy that could potentially inhibit cell proliferation on the device is reported. It is realized by pairing iron with a biocompatible hydrogel cathode in a cell culture media-based electrolyte forming an iron-air battery. This system does not show cytotoxicity to human adipose-stem cells over a period of 21 days but inhibits cell proliferation. The combination of enhanced iron degradation and inhibited cell proliferation by this dynamic method suggests it might be an approach for restenosis inhibition of biodegradable stents.
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  • 文章类型: Journal Article
    背景:胆道吻合术后良性胆道狭窄(BBS)的治疗需要多学科方法,包括手术,放射学,和/或内窥镜输入。患者通常需要多次住院治疗,长期有再狭窄的可能性。通常,BBS已通过连续的经皮肝穿胆道扩张术进行治疗,因此需要重复进行引流或去除引流。难治性狭窄可能需要手术。在过去的十年里,越来越多的报道称,使用可生物降解支架(BDS)治疗胆道狭窄,主要是为了解决反复进行引流换管的需要.
    目的:本研究旨在报告BDS治疗的BBS患者的早期结局。
    方法:回顾性分析前瞻性收集的病例数据,这些病例表现为吻合口狭窄,并打算用BDS治疗。报告的主要终点是技术成功(定义为重复胆管造影成功解决狭窄)和临床成功(定义为没有重复胆管炎)。报告Clavien-Dindo(CD)级并发症。
    结果:12例患者出现BBS,9例患者出现BDS。由于不可穿越的狭窄,三名患者被认为不适合BDS,并接受了手术。男女比例为1:2。有100%的技术和临床成功,其中一名患者的支架迁移不需要干预。该过程平均花费45分钟。在7名(77.7%)患者中,在局部麻醉和镇静下安全地进行.两名患者首选全身麻醉。在中位随访11个月时没有发现再狭窄。
    结论:使用BDS治疗BBS是一种安全有效的方法。需要在国家数据库上进行多机构报告的长期后续行动,以评估其长期利益。
    BACKGROUND: Management of benign biliary strictures (BBS) post bilioenteric anastomoses requires a multidisciplinary approach including surgical, radiological, and/or endoscopic input. Patients often need multiple hospital visits for treatment with the long-term possibility of restenosis. Conventionally BBS have been treated with serial percutaneous transhepatic biliary dilatations necessitating repeat procedures for drain exchange or removal. Surgery may become necessary in refractory strictures. In the last decade, there have been increasing reports of the use of biodegradable stents (BDS) in treating biliary strictures mainly to address the need for repeated procedures for drain exchange.
    OBJECTIVE:  This study aimed to report the early outcomes in patients with BBS treated with BDS.
    METHODS: Retrospective analysis of prospectively collected data was performed in patients who had a bilioenteric anastomosis presenting with an anastomotic stricture and were intended to be treated with BDS. The primary endpoints reported were technical success (defined as a successful resolution of stricture on repeat cholangiogram) and clinical success (defined as the absence of repeated cholangitis). Clavien-Dindo (CD) grade of complication was reported.
    RESULTS: Twelve patients presented with BBS and nine patients had BDS. Three patients were not considered suitable for BDS due to a non-traversable stricture and had surgery. The male-female ratio was 1:2. There was 100% technical and clinical success with one patient having stent migration not needing intervention. The procedure took an average of 45 min. In seven (77.7%) patients, it was safely performed under local anesthesia with sedation. Two patients preferred general anesthesia. There was no restenosis noted at a median follow-up of 11 months.
    CONCLUSIONS: The use of BDS in the treatment of BBS is a safe and effective procedure. Longer-term follow-up with multi-institutional reporting on a national database is needed to assess its long-term benefits.
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  • 文章类型: Journal Article
    The degradation time is a crucial factor in evaluating the performance of poly (lactic-co-glycolic acid) (PLGA) stents. Bulk degradation mode was commonly used to analyze the stent degradation behavior by finite element approach. However, the PLGA stents may present surface degradation more than bulk degradation under certain conditions, which will greatly affect the degradation time after implantation. In this study, the degradation processes of the poly (lactic-co-glycolic acid) stent were reproduced utilizing finite element analysis. Both bulk degradation and surface degradation modes were considered. The correlation between tensile stress and degradation rate was investigated. The degradation time was analyzed selectively. The stress distribution, fracture, and mass loss were also compared between bulk degradation mode and surface degradation mode. The simulation results showed that, in both evolution modes, the degradation began at the \'peak-valley\' region and fracture occurred at the cross of links and rings. Additionally, high levels of Von-Mises stress were observed in these two regions. Compared with bulk degradation, the fracture time of the stent was delayed by 63% in the surface degradation mode. In conclusion, the mass loss rate and scaffolding period showed great differences between surface degradation and bulk degradation. Based on this study, it is suggested that bulk degradation mode is not applicable to the case of inadequate water uptake mode, such as the tracheal stent degradation process. More experimental research should be carried out to accurately predict the scaffolding period after implantation. The mechanical properties of the fracture zone should be strengthened.
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  • 文章类型: Journal Article
    Biodegradable magnesium (Mg)-based vascular stents can overcome the limitations of conventional permanent metallic stents, such as late in-stent restenosis and thrombosis, but still have difficulty retarding degradation while providing adequate mechanical support to the blood vessel. We incorporated silica nanoparticles surface-functionalized with hexadecyltrimethoxysilane (mSiNP) into a poly (l-lactic acid) (PLLA) coating as a physical barrier to disturb the penetration of the corrosive medium as well as a bioactive source that releases silicon ions capable of stimulating endothelial cells. The corrosion resistance and biocompatibility of this bifunctional PLLA/mSiNP nanocomposite coating were investigated using different weight ratios of mSiNP. The nanocomposite coating containing more than 10 wt% of the mSiNP (PLLA/10mSiNP and PLLA/20mSiNP) significantly delayed the corrosion of the Mg substrate and exhibited favorable endothelial cell responses, compared to the pure PLLA coating. Specifically, the calculated corrosion rates of PLLA/10mSiNP and PLLA/20mSiNP decreased by half, indicating the durability of the coating after immersion in simulated body fluid for 12 days. Based on the in vitro cellular response, the incorporation of the mSiNPs into the PLLA coating significantly improved the endothelial cell responses to the Mg substrate, showing better initial cell surface coverage, migration, and proliferation rate than those of pure PLLA. These results indicate that the PLLA/mSiNP nanocomposite coatings have significant potential to improve the corrosion resistance and vascular compatibility of biodegradable Mg-based vascular stents.
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  • 文章类型: Journal Article
    UNASSIGNED: Tracheobronchial stents types, uses, techniques for deployment and extraction have practice variations around the world.
    UNASSIGNED: We collected responses by sending an online survey of 8 questions to world interventional bronchology member societies and social media groups.
    UNASSIGNED: There were 269 respondents from 47 countries. Europe had 97 respondents from 22 countries. There were 8 respondents from Australia, 7 from Africa (3 countries) and 7 from 4 countries in South America (SA). North America (NA) had 72 respondents from 3 countries. Asia had 78 respondents from 14 countries. For stent placements 15% [41] used fiberoptic bronchoscope (FB) only. Rigid bronchoscopy (RB) was solely utilized by 38% [102]. Forty-six percent [123] used a combination of RB and FB (P value <0.00001). For stent extraction 13% [19] used FB alone, 57% [85] used RB, and 36% [54] used a combination of RB and FB (P value <0.00001). Placement of stents were 50.5% [135] only by direct visualization. Twenty-three percent [61] always used fluoroscopic guidance. Twenty-six-point-five percent [71] used fluoroscopy in certain cases (P value <0.00001). Sixty percent [162] decided stent sizing by measurements of stenotic and non-stenotic areas on radiology. Twelve percent [32] respondents used sizing devices. Sixty-five percent [177] used a ruler and bronchoscope to measure stenotic areas. Thirty-eight percent [104] used visual estimation and experience. Seven percent [19] used serial balloon dilatation size. To prevent clogging of stents, 22% [59] prescribed mucolytics. Seventy-three percent [195] nebulized saline, 26% [70] had Mucomyst Nebulization, 24% [65] Nebulized bronchodilators and other methods 11% [30] were advised. Covered self-expandable metal stents (SEMS) 44% was the commonest type of stent used around the world. Silicone stents 37%, Y stents 15%, uncovered SEMS 12%, Montgomery T tube 5% followed. Polyflex stents 3% and custom-made stents 3% were least used. Biodegradable stents were used by 7.5%, and not used by 92.5%.
    UNASSIGNED: Tracheobronchial stent practice norms have slowly evolved, but its practice variations lack uniformity, and have sparse evidence-based studies for its direction.
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  • 文章类型: Journal Article
    目的:手术解剖改变使胰胆管树的内镜手术复杂化。胆道或肝空肠吻合狭窄已使用经皮肝穿或双气囊小肠镜(DBE)技术和多个塑料支架进行了治疗。或完全覆盖自膨胀金属支架。我们报告了前7例采用DBE可生物降解支架治疗的手术解剖结构改变的病例。
    方法:7例解剖结构改变,全部采用Roux-en-Y肝空肠吻合术(HJ),治疗HJ吻合口狭窄(3例)和肝内胆管狭窄(4例)。使用具有200cm长和3.2mm宽的工作通道的FujifilmDB肠镜。首先进行球囊扩张,然后在导丝上使用推动器展开1-3个可生物降解的支架。
    结果:两名患者因肝脏切除而患有HJ,一个是由于胆囊切除术中的胆道损伤,四个是由于原发性硬化性胆管炎(PSC)引起的肝移植。手术的中位持续时间为56分钟。每位患者的支架部署时间不到20分钟。无支架或胆道造影相关不良事件,但有1例患者因放置鼻咽管引起的鼻出血需要气管插管。2例PSC患者在随访中复发胆管炎。90天随访1例支架移位。通过所有HJ吻合狭窄,似乎可以实现狭窄的解决。
    结论:在解剖结构改变的胆道或吻合口狭窄的治疗是复杂且耗时的。生物可降解支架,可以通过长肠镜的工作通道,在治疗这些狭窄方面似乎很有希望。益处是不需要移除支架。
    OBJECTIVE: Surgically altered anatomy complicates endoscopical procedures of pancreatobiliary tree. Biliary or hepaticojejunal anastomosis strictures have been managed using percutaneous transhepatic or double balloon enteroscopy (DBE) techniques with multiple plastic stents, or fully covered self-expandable metal stents. We report the first seven cases with surgically altered anatomy treated with biodegradable stents with DBE.
    METHODS: Seven cases with altered anatomy, all with Roux-en-Y hepaticojejunostomy (HJ), were treated for HJ anastomosis strictures (3 cases) and intrahepatic biliary stricture (4 cases). Fujifilm DB enteroscope with a 200 cm long and 3.2 mm wide working channel was used. Balloon dilatations were first performed and then 1-3 biodegradable stents were deployed with a pusher over a guidewire.
    RESULTS: Two patients had HJ due to liver resections, one due to biliary injury in cholecystectomy and four due to liver transplantation because of primary sclerosing cholangitis (PSC). Median duration of the procedures was 56 min. Deployment of the stents took less than 20 min per patient. There were no stent or cholangiography related adverse events, but one patient required endotracheal intubation for nose bleeding caused by the placement of nasopharyngeal tube. Two PSC patients had recurrent cholangitis in the follow up. There was one stent migration in 90 day follow up. With all the HJ anastomotic strictures resolution of strictures seemed to be achieved.
    CONCLUSIONS: Treatment of biliary or anastomosis strictures in altered anatomy is complex and time consuming. The biodegradable stent, which can be passed through working channel of a long enteroscope, seems promising in the treatment of these strictures. The benefit is that no stent removal is needed.
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