Biodegradable stent
DeviceBronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant
NCT Number: NCT05334199
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
AMC, Amsterdam, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant
Time frame: 4 months after placement
Adverse events associated with airway stents
Time frame: 1 week post placement
Change in FEV1 measured by spirometry pre and post stent placement
Time frame: 1 week post placement
Change in FVC measured by spirometry pre and post stent placement
Time frame: 6 months after placement
Endurance and life span of biodegradable stent measured by time to need for new stent placement
University Medical Center Groningen
Other
Evaluation of Treatment With Biodegradable Airway Stent for Post Lung Transplant Airway Complication
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