AbstractUreteral obstruction is a prevalent urological condition associated with significant complications. The purpose of our study was to assess the safety and efficacy of a novel self-expanding, large caliber, biocompatible polymer-coated ureteral stent (Allium) for the treatment of ureteral obstructions.

摘要输尿管梗阻是一种常见的泌尿系统疾病，伴有严重的并发症。我们研究的目的是评估一种新型自扩张，大口径，生物相容性聚合物涂层输尿管支架（Allium）治疗输尿管梗阻的安全性和有效性。

We conducted a retrospective analysis of data from patients who underwent Allium ureteral stent placement at our institute between November 2018 and May 2023. Demographic, clinical, and perioperative parameters were collected and analyzed. Logistic regression analyses were performed to identify preoperative factors predicting Allium stent migration.

我们对2018年11月至2023年5月期间在我们研究所接受Allium输尿管支架置入术的患者的数据进行了回顾性分析。收集并分析人口统计学，临床和围手术期参数。进行逻辑回归分析以确定预测Allium支架迁移的术前因素。

The study cohort comprised 30 patients who received a total of 40 successfully implanted Allium stents. No significant adverse events related to the insertion procedure were observed. During a median follow-up period of 29 months (range: 1–60 months), migration occurred in 11 (27.5%) stents while encrustation was noted in 8 (20%) stents.

该研究队列包括30名患者，他们共成功植入了40个Allium支架。没有观察到与插入程序相关的重大不良事件。在中位随访29个月（范围：1-60个月）期间，11个（27.5%）支架发生迁移，8个（20%）支架出现结痂。

The median functional duration of the Allium stents was found to be 22 months (range:1–60 months), with an overall functioning rate at last follow-up being recorded as 59.5%. Multivariate analysis revealed that the glomerular filtration rate of the ipsilateral kidney was the sole risk factor predictive of Allium stent migration.

Allium支架的中位功能持续时间为22个月（范围：1-60个月），最后一次随访的总体功能率为59.5%。多变量分析显示，同侧肾脏的肾小球滤过率是预测Allium支架移位的唯一危险因素。

With its minimal invasiveness and good tolerability, the Allium stent represents a safe and viable management option for treating ureteric obstructions; however, it should not be considered as definitive treatment but rather as an alternative option for patients unwilling or unsuitable for definitive treatment, particularly high-risk individuals or elderly patients exhibiting decreased ipsilateral glomerular filtration rates..

Allium支架具有微创性和良好的耐受性，是治疗输尿管梗阻的安全可行的管理选择；然而，它不应被视为确定性治疗，而应被视为不愿意或不适合确定性治疗的患者的替代选择，特别是高危人群或同侧肾小球滤过率降低的老年患者。。

IntroductionUreteral obstruction is a prevalent urological condition that can arise from either malignancies or benign factors, such as impacted calculi, radiotherapy, or other diseases. It can be asymptomatic or manifests as flank pain, urinary tract infection, and may even result in non-functioning kidneys1.

引言输尿管梗阻是一种普遍的泌尿系统疾病，可能由恶性肿瘤或良性因素引起，如受影响的结石，放疗或其他疾病。它可能无症状或表现为腰痛，尿路感染，甚至可能导致肾脏功能不全1。

Various treatment options are available for managing ureteral obstructions including reconstructive surgery, percutaneous nephrostomy, or double-J stents2. Despite the satisfactory outcomes achieved with robot-assisted ureteroplasty nowadays, it is associated with relatively high rates of complications3.

各种治疗选择可用于治疗输尿管梗阻，包括重建手术，经皮肾造口术或双J支架2。尽管目前机器人辅助输尿管成形术取得了令人满意的结果，但并发症发生率相对较高3。

In patients who are unwilling or unfit for definitive treatment—especially those at high risk or elderly individuals—ureteral stents can be employed.Despite the advantages of minimal invasiveness and ease of insertion, double-J stents are associated with potential adverse side effects such as pain, hematuria, infection, symptoms of bladder irritation, stent migration, and encrustation necessitating frequent replacement (every few months)4.

对于不愿意或不适合进行明确治疗的患者，尤其是高危患者或老年人，可以使用输尿管支架。尽管具有微创性和易于插入的优点，但双J支架与潜在的不良副作用有关，如疼痛，血尿，感染，膀胱刺激症状，支架移位和结痂，需要频繁更换（每隔几个月）4。

Moreover, the placement of double-J stents usually leads to lower urinary tract symptoms (LUTS), resulting in a diminished quality of life. Consequently, several segmental stents made preferably from metal have been introduced to address the aforementioned issues and limitations by allowing long-term or permanent indwelling5.The Allium stent (Allium, Allium LTD, Caesarea, Israel) is a novel large caliber self-expanding ureteral stent composed of nitinol and coated with a biocompatible polymer to prevent tissue ingrowth and encrustation6.

此外，双J支架的放置通常会导致下尿路症状（LUTS），导致生活质量下降。因此，已经引入了几种优选由金属制成的节段性支架，以通过允许长期或永久性留置来解决上述问题和局限性5。Allium支架（Allium，Allium LTD，Caesarea，Israel）是一种新型大口径自膨胀输尿管支架由镍钛诺组成，并涂有生物相容性聚合物，以防止组织向内生长和结垢6。

The initial study on the use of the Allium stent for managing chronic ureteral obstructions was conducted by Moskovitz et al. in 20127. However, limited research has been conducted thus far rega.

。然而，到目前为止，rega进行的研究有限。

Data availability

数据可用性

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

本研究中使用和/或分析的数据集可根据合理要求从通讯作者处获得。

AbbreviationsCT:

缩写：

Computed tomography

计算机断层扫描

GFR:

GFR：

Glomerular filtration rate

肾小球滤过率

BMI:

体重指数：

Body mass index

体重指数

KUB:

库布：

Kidney, ureters and bladder

肾脏、输尿管和膀胱

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Download referencesFundingSupported by Beijing Municipal Natural Science Foundation (Grant No. 7222239).Author informationAuthors and AffiliationsDepartment of Urology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, No. 168 Litang Road, Changping District, Beijing, 102218, ChinaBoxing Su, Weiguo Hu, Bo Xiao, Yubao Liu, Gang Zhang, Yuzhe Tang & Jianxing LiAuthorsBoxing SuView author publicationsYou can also search for this author in.

下载北京市自然科学基金（批准号7222239）支持的参考基金。作者信息作者和附属机构清华大学临床医学院北京清华长庚医院泌尿外科，北京市昌平区理塘路168号，102218，ChinaBoxing Su，Weiguo Hu，Bo Xiao，Yubao Liu，Gang Zhang，Yuzhe Tang＆Jianxing Liauthors Boxing SuView作者出版物您也可以在中搜索这位作者。

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PubMed Google ScholarContributionsS.B.X.: Protocol development, Data collection and management, Data analysis, Manuscript writing/editing. H.W.G., X.B. and Z.G. : Data collection. X.B.: Data analysis, Manuscript editing. L.Y.B.: Manuscript editing, data analysis. T.Y.Z.: Data analysis.

PubMed谷歌学术贡献。B、 X.：协议开发，数据收集和管理，数据分析，稿件撰写/编辑。H、 W.G.，X.B.和Z.G.：数据收集。十、 B.：数据分析，手稿编辑。五十、 Y.B.：手稿编辑，数据分析。T、 Y.Z.：数据分析。

L.J.X.: Protocol development, Project development, Data analysis, Manuscript editing.Corresponding authorCorrespondence to.

五十、 J.X.：协议开发，项目开发，数据分析，手稿编辑。对应作者对应。

Jianxing Li.Ethics declarations

李建兴。道德宣言

Competing interests

相互竞争的利益

The authors declare no competing interests.

作者声明没有利益冲突。

Consent for publication

同意出版

Written informed consent was obtained from all subjects to use their data and information for publication.

所有受试者均获得书面知情同意书，以使用其数据和信息进行发布。

Ethical approval and consent to participate

道德认可和参与同意

This study was approved by the Beijing Tsinghua Changgung Hospital Ethics Committee and conducted in accordance with the standards laid down in the Declaration of Helsinki. All patients provided informed consent.

这项研究得到了北京清华长庚医院伦理委员会的批准，并按照《赫尔辛基宣言》中规定的标准进行。所有患者均提供知情同意书。

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Reprints and permissionsAbout this articleCite this articleSu, B., Hu, W., Xiao, B. et al. Long-term outcomes of Allium ureteral stent as a treatment for ureteral obstruction.

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KeywordsUreterObstructionEndoscopicUreteral stent

关键词混凝土结构内窥镜

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