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OpenTrials
Completed

NCT Number: NCT05334199

Biodegradable Airway Stent Post Lung Transplant

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMC, Amsterdam, Netherlands

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No

Treatment and study plan

Biodegradable stent

Device

Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant

Primary outcomes

  1. Adverse events

    Time frame: 4 months after placement

    Adverse events associated with airway stents

Secondary outcomes

  1. Change in FEV1

    Time frame: 1 week post placement

    Change in FEV1 measured by spirometry pre and post stent placement

  2. Change in FVC

    Time frame: 1 week post placement

    Change in FVC measured by spirometry pre and post stent placement

  3. Time to need for new stent placement

    Time frame: 6 months after placement

    Endurance and life span of biodegradable stent measured by time to need for new stent placement

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • AIDS Malignancy Consortium

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.