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NOT YET RECRUITING
NCT07627594

Safety of Bronchoscopy in Patients With Interstitial Lung Disease

Sponsor: University of Milan

View on ClinicalTrials.gov

Summary

Bronchoscopy is an essential technique, routinely used in the differential diagnosis workup of many Interstitial Lung Diseases (ILDs) and in referral centres is a common procedure. Bronchoalveolar lavage (BAL), bronchial and transbronchial biopsies with forceps and cryoprobes, and lymph node sampling with endosonography represent the most used sampling techniques in these patients. However, patients with ILDs refer to medical attention in a wide range of clinical conditions from mild functional impairment, with absent or few respiratory symptoms, to severe lung involvement with low exercise tolerance and/or chronic respiratory failure. In these patients, a balance between benefits and risk, i.e. to the safety and diagnostic utility of bronchoscopy should be always carefully evaluated. Moreover, there is a wide variability in adverse events entity and frequency depending by procedures performed during bronchoscopy. Despite its crucial utility, only few data are available in the literature on the safety of bronchoscopy in patients with ILDs and limited data on the utility and safety of this sampling technique are present in patients with AE-ILDs. The primary aim of this study is to assess the overall rate of complications occurring within 24 hours after bronchoscopy. Study rate and type of complications occurring during the endoscopic procedure, within 30 days after bronchoscopy, in patients with AE-ILDs, among fibrotic Vs non-fibrotic ILD, and according to each employed sampling technique will be also recorded.

Official title: Safety of Bronchoscopy in Patients With Interstitial Lung Disease: A Prospective, Observational, Multicentre, International Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

427

Start Date

2026-06-01

Completion Date

2028-05-30

Last Updated

2026-06-04

Healthy Volunteers

No

Locations (11)

- Service de Pneumologie Allergologie et Transplantation, Centre Constitutif du Centre de Référence des Maladies Pulmonaires Rares, FHU INFIRE, Paris, France

Paris, France

Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy), Milano, Lombardia 20142

Milan, Lombardy, Italy

Respiratory Unit, Azienda Ospedaliera-Universitaria IRCCS Policlinico di Sant'Orsola Malpighi, Bologna, Italy

Bologna, Italy

Unit of Pneumology, San Martino Policlinic Hospital, Genoa, Italy

Genova, Italy

Respiratory Unit - Legnano Hospital, ASST Ovest Milanese

Legnano, Italy

Division of Respiratory Diseases, Ospedale Luigi Sacco, Polo Universitario, ASST Fatebenefratelli-Sacco

Milan, Italy

Respiratory Unit - Center for Rare Lung Disease - Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy

Modena, Italy

Respiratory Unit - IRCCS San Gerardo dei Tintori Foundation, Monza

Monza, Italy

Interventional Pulmonology Unit, Department of Pulmonology, Oncology and Hematology, Antonio Cardarelli Hospital, Naples, Italy

Naples, Italy

Unit of Respiratory Medicine "L. Vanvitelli", A.O. dei Colli, Monaldi Hospital, Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy

Naples, Italy

Respiratory Unit, Santa Maria alle Scotte University Hospital, Siena

Siena, Italy