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| Name | Class |
|---|---|
| AIDS Malignancy Consortium | NETWORK |
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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
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biodegradable stent treatment group | Experimental | Biodegradable stent treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodegradable stent | Device | Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events associated with airway stents | 4 months after placement |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 | Change in FEV1 measured by spirometry pre and post stent placement | 1 week post placement |
| Change in FVC | Change in FVC measured by spirometry pre and post stent placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk-Jan Slebos, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMC | Amsterdam | Netherlands | ||||
| UMCG |
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| 1 week post placement |
| Time to need for new stent placement | Endurance and life span of biodegradable stent measured by time to need for new stent placement | 6 months after placement |
| Groningen |
| Netherlands |