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Biodegradable Airway Stent Post Lung Transplant

2022年4月19日 更新者:Dirk-Jan Slebos、University Medical Center Groningen

Evaluation of Treatment With Biodegradable Airway Stent for Post Lung Transplant Airway Complication

Introduction and rationale

Benign airway stenosis or malacia is a frequent complication of lung transplantation occurring in 4-24% of patients, most often occurring two to nine months post-transplant. Initial therapeutic approach consists of conservative endobronchial treatment with recurrent balloon dilatation, radial incision, and electro cautery. For severe case of recurrent stenosis or malacia, airway stent placement can be considered. Different types of airway stent exist, for instance self-extendable metallic stent (SEMS), silicone stent and biodegradable airway stent. Conventional airway stents (SEMS, silicone) are associated with complications as granulation tissue and recurrent infections and can be difficult to remove. Newly developed biodegrabale stents are made of polydioxanone and disintegrate after a period of time are thought to have less side effects, and has been standard of care for the last few years. A sub selection of patients have been treated with conventional stent before treated with biodegradable stent.

Research question

  • To assess the efficacy and efficiency of biodegradable airway stent.
  • Compare occurrence of adverse events such as infection, dislocation, in stent granulation and difficulty of removal to conventional metallic or silicone stents.
  • Asses if biodegradable stent lead to improvement of lung function.
  • Assessment of the life span of biodegradable stents.

研究概览

详细说明

  • Background Recurrent airway stenosis or malacia can be treated with airway stents. Conventional airway stents, for instance self-extendable metallic stent (SEMS) and silicone stent are associated with adverse events as recurrent infection or granulation tissue and can be difficult to remove because of in stent-granulation. Therefore they are used with restraint for benign airway problems. Biodegradable stents are made of polydioxanone and disintegrate after a period of time. They are thought to be well tolerated and associated with less adverse events compared to traditional airway stent and have been used as standard care for multiple years.
  • Main research question

    • To assess the efficacy and efficiency of biodegradable airway stent
    • Compare occurrence of adverse events such as infection, dislocation, in stent granulation and difficulty of removal to conventional metallic or silicone stents.
    • Asses if biodegradable stent lead to improvement of lung function.
    • Assessment of the life span of biodegradable stents.
  • Design (including population, confounders/outcomes) Retrospective cohort study of patients with airway stenosis or malacia treated with biodegradable airway stent from 2019 in the UMCG and Amsterdam UMC.
  • Expected results

    • Less adverse events, hospital admittance and need for bronchoscopic interventions compared to patients treated with conventional stents. No complications associated with removal of stents.
    • Life span around 4 months

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Amsterdam、荷兰
        • AMC
      • Groningen、荷兰
        • UMCG

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients who underwent a lung transplantation and developed airway stenosis or malacia with airway stent requirement

Exclusion Criteria:

  • No

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Biodegradable stent treatment group
Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Adverse events
大体时间:4 months after placement
Adverse events associated with airway stents
4 months after placement

次要结果测量

结果测量
措施说明
大体时间
Change in FEV1
大体时间:1 week post placement
Change in FEV1 measured by spirometry pre and post stent placement
1 week post placement
Change in FVC
大体时间:1 week post placement
Change in FVC measured by spirometry pre and post stent placement
1 week post placement
Time to need for new stent placement
大体时间:6 months after placement
Endurance and life span of biodegradable stent measured by time to need for new stent placement
6 months after placement

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dirk-Jan Slebos, MD, PhD、UMCG

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年4月2日

初级完成 (实际的)

2022年3月31日

研究完成 (实际的)

2022年3月31日

研究注册日期

首次提交

2022年3月31日

首先提交符合 QC 标准的

2022年4月11日

首次发布 (实际的)

2022年4月19日

研究记录更新

最后更新发布 (实际的)

2022年4月27日

上次提交的符合 QC 标准的更新

2022年4月19日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 20220075

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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