Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203964
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2024-01-02
Brief Title:
Organizing Pneumonia in Lung Transplant Recipients a Restrospective Exploratory Study OPIL-Study
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Organizing Pneumonia in Lung Transplant Recipients a Restrospective Exploratory Study OPIL-Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPIL
Brief Summary:
The aim of this study is to generate evidence regarding organizing pneumonia in lung transplant recipients
Detailed Description:
Allograft failure remains the leading cause of morbidity and mortality in lung transplant recipients LTR accounting for 40 of deaths beyond the first year after transplantation The current median survival over all LTRs is 60 years Chronic allograft dysfunction CLAD is defined as a substantial and persistent decline in the measured forced expiratory volume in 1 second FEV1 with 20 from the baseline value The consensus statement from the International Society for Heart and Lung Transplantation in 2019 classified CLAD into two main phenotypes Bronchiolitis obliterans syndrome BOS and restrictive allograft syndrome RAS Based on respiratory function and computed tomography CT findings CLAD is classified into four groups BOS RAS mixed BOS and RAS and undefined Definite CLAD-BOS is defined as persistent decline of 20 from the reference value after more than 3 months without a restriction and without persistent radiologic pulmonary opacities
The main histologic findings of BOS include obliterative bronchiolitis OB accompanying chronic inflammation and fibrosis in the respiratory tract
Up to 30 of patients with CLAD present a restrictive pattern stated as CLAD-RAS CLAD-RAS is physiologically defined as a persistent decline in FEV1 FVC of 20 compared with the reference or baseline value a decrease in total lung capacity TLC to 90 compared with baseline and the presence of persistent opacities on chest imaging The pathology of RAS is nearly identical to that observed in the entity of pleuroparenchymal fibroelastosis It features severe alveolar fibrosis organized around the pleura and the interlobular septa with concomitant obliterative bronchiolitis lesions Von der Thüsen et al analysed tissue samples of 21 patients with RAS describing not only patterns consistent with pleuroparenchymal fibroelastosis but also nonspecific interstitial pneumonia irregular emphysema organizing pneumonia OP and acute fibrinous organizing pneumonia AFOP
Some authors have advocated acute fibrinoid and organizing pneumonia AFOP as a third potential form of chronic allograft dysfunction with decline of lung functions as for CLAD but with distinct histopathology and imaging findings Paraskeva et al identified AFOP as a novel entity in 22 out of 194 11 lung transplant recipients invariably associated with a rapid decline in respiratory function and death after a median time of 101 days AFOP is a unique pathological entity with intra-alveolar fibrin in the form of fibrin balls and organizing pneumonia
While AFOP and its clinical impact is getting more and more recognized as a pattern of RAS little is known about OP and its clinical impact in LTRs OP per se is a pattern of lung tissue repair after injury It can be a response to a specific lung injury secondary OP or cryptogenic COP COP has no identifiable cause and is classified as a form of idiopathic diffuse parenchymal lung disease DPLD So far it is not clear if OP is a form of the RAS spectrum and if the presence of OP might also predict a rapid decline in lung function and survival comparable with AFOP
The aim of this study is to investigate the prevalence of OP forms in lung transplant recipients possible risk factors for OP and the impact of OP itself on the course of lung allograft function
The main histologic findings of BOS include obliterative bronchiolitis OB accompanying chronic inflammation and fibrosis in the respiratory tract
Up to 30 of patients with CLAD present a restrictive pattern stated as CLAD-RAS CLAD-RAS is physiologically defined as a persistent decline in FEV1 FVC of 20 compared with the reference or baseline value a decrease in total lung capacity TLC to 90 compared with baseline and the presence of persistent opacities on chest imaging The pathology of RAS is nearly identical to that observed in the entity of pleuroparenchymal fibroelastosis It features severe alveolar fibrosis organized around the pleura and the interlobular septa with concomitant obliterative bronchiolitis lesions Von der Thüsen et al analysed tissue samples of 21 patients with RAS describing not only patterns consistent with pleuroparenchymal fibroelastosis but also nonspecific interstitial pneumonia irregular emphysema organizing pneumonia OP and acute fibrinous organizing pneumonia AFOP
Some authors have advocated acute fibrinoid and organizing pneumonia AFOP as a third potential form of chronic allograft dysfunction with decline of lung functions as for CLAD but with distinct histopathology and imaging findings Paraskeva et al identified AFOP as a novel entity in 22 out of 194 11 lung transplant recipients invariably associated with a rapid decline in respiratory function and death after a median time of 101 days AFOP is a unique pathological entity with intra-alveolar fibrin in the form of fibrin balls and organizing pneumonia
While AFOP and its clinical impact is getting more and more recognized as a pattern of RAS little is known about OP and its clinical impact in LTRs OP per se is a pattern of lung tissue repair after injury It can be a response to a specific lung injury secondary OP or cryptogenic COP COP has no identifiable cause and is classified as a form of idiopathic diffuse parenchymal lung disease DPLD So far it is not clear if OP is a form of the RAS spectrum and if the presence of OP might also predict a rapid decline in lung function and survival comparable with AFOP
The aim of this study is to investigate the prevalence of OP forms in lung transplant recipients possible risk factors for OP and the impact of OP itself on the course of lung allograft function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None