Biodegradable Stents in the Management of Stenoses of the Large Airways
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- airway patency during the presence of the stent in the airways
研究概览
简要总结
The objective of this project is to determine whether biodegradable polydioxanone stents are efficient in the treatment of adult patients with tracheobronchial stenoses.
详细描述
Background:
The ideal airway stent has yet to be developed. Biodegradable (BD) stents are made of knitted polymer fibers that degrade when placed in the body; extraction of the device is, therefore, unnecessary. Several in vitro and in vivo studies of tracheal BD stents composed of various materials have been conducted.
Polydioxanone is a biodegradable polymer in the polyester family, which has attracted a lot of interest due to its exquisite biocompatibility and is currently available on the market in the form of absorbable suture material. It is degraded by hydrolysis (of its ester bonds), which is accelerated under low potential of Hydrogen (pH) conditions, into harmless degradation products. Polydioxanone tracheal stents appear to be well tolerated by the tracheal mucosa, retain their mechanical strength for as long as 6 weeks, and, in animal models, completely degrade after approximately 15 weeks. They have been successfully used in humans as mechanical support for tracheal transplants, during treatment of obstructive airway complications after lung transplantation, and in children with airway stenosis.
Hypotheses:
Biodegradable stents can be used in adult patients as a temporary mechanical support of narrowed airways, they allow healing of the airways or secure the airways until another (anticancer, anti-inflammatory) therapy manages the cause of the narrowing. Biodegradable stents are expected to have advantages over classical stents, namely good biocompatibility, fair adaptation to the anatomy of the airways, they do not limit the transportation of secretions substantially.
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
- •significant large airway stenoses
- •benign tracheobronchial stenosis of any origin in participants who can not go for surgery, or who refuse surgical treatment
- •benign tracheobronchial stenoses of any origin when the surgery is planed after some delay, benign tracheobronchial stenoses when the effect of anti- inflammatory or anti-infective treatment is expected
- •malignant tracheobronchial stenoses due to extrinsic compression when exhausted curative modalities
- •malignant stenoses from extrinsic compression in participants undergoing the actinotherapy or receiving systemic anticancer therapy
排除标准
- •stenoses of any origin which can be treated primarily surgically
- •stenoses caused by intraluminal growth of tumor, tracheoesophageal or bronchoesophageal fistulas
- •pregnancy
结局指标
主要结局
airway patency during the presence of the stent in the airways
时间窗: residence time of the stent in the airways, i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support
Scheduled bronchoscopies, trachea is, for the purposes of the study, classified according to Freitag's recommended adapted classification system (Freitag L. et al. A proposed classification system of central airway stenosis, Eur Respir J 2007; 30:7-12).
次要结局
- number of complications: infection, bleeding, migration, obstructive granulation tissue formation, sudden restenosis (of any origin, unexpected in relation to the degree of the stent degradation)(residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter)
- evaluation of forced vital capacity (FVC)(residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter)
- airway patency after complete degradation of the stent or loss of majority support functions(six months, beginning after identifying the complete degradation of the stent or 180 days after implantation)
- evaluation of forced expiratory volume in 1 second (FEV1)(residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter)
研究者
Ludek Stehlik
MUDr.
Thomayer University Hospital