Evaluation of Treatment With Biodegradable Airway Stent for Post Lung Transplant Airway Complication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
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.
详细描述
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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.
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Main research question
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To assess the efficacy and efficiency of biodegradable airway stent
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Compare occurrence of adverse events such as infection, dislocation, in stent granulation and difficulty of removal to conventional metallic or silicone stents.
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Asses if biodegradable stent lead to improvement of lung function.
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Assessment of the life span of biodegradable stents.
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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.
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Expected results
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Less adverse events, hospital admittance and need for bronchoscopic interventions compared to patients treated with conventional stents. No complications associated with removal of stents.
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Life span around 4 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent a lung transplantation and developed airway stenosis or malacia with airway stent requirement
排除标准
- 未提供
结局指标
主要结局
Adverse events
时间窗: 4 months after placement
Adverse events associated with airway stents
次要结局
- Change in FEV1(1 week post placement)
- Change in FVC(1 week post placement)
- Time to need for new stent placement(6 months after placement)
研究者
Dirk-Jan Slebos
Prof. dr.
University Medical Center Groningen