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Biodegradable Airway Stent Post Lung Transplant

NCT05334199 NA COMPLETED

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.

Details

Lead sponsorUniversity Medical Center Groningen
PhaseNA
StatusCOMPLETED
Enrolment20
Start dateTue Apr 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionThu Mar 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Netherlands