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Safety of Bronchoscopy in Patients With Interstitial Lung Disease (SaBrILD)

29 maggio 2026 aggiornato da: Michele Mondoni, University of Milan

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

427

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Francia
      • Paris, Francia, 75877
        • - Service de Pneumologie Allergologie et Transplantation, Centre Constitutif du Centre de Référence des Maladies Pulmonaires Rares, FHU INFIRE, Paris, France
        • Contatto:
        • Investigatore principale:
          • Bruno Crestani, MD, Professor
  • Italia
      • Bologna, Italia, 38050
        • Respiratory Unit, Azienda Ospedaliera-Universitaria IRCCS Policlinico di Sant'Orsola Malpighi, Bologna, Italy
        • Contatto:
        • Investigatore principale:
          • Piero Candoli, MD
      • Genova, Italia, 16132
        • Unit of Pneumology, San Martino Policlinic Hospital, Genoa, Italy
        • Investigatore principale:
          • Emanuela Barisione, MD
        • Contatto:
      • Legnano, Italia, 20025
        • Respiratory Unit - Legnano Hospital, ASST Ovest Milanese
        • Contatto:
        • Investigatore principale:
          • Paolo Carlucci, MD
      • Milan, Italia, 20157
        • Division of Respiratory Diseases, Ospedale Luigi Sacco, Polo Universitario, ASST Fatebenefratelli-Sacco
        • Contatto:
        • Investigatore principale:
          • Pierachille Santus, MD, Professor
      • Modena, Italia, 41124
        • Respiratory Unit - Center for Rare Lung Disease - Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy
        • Contatto:
        • Investigatore principale:
          • Stefania Cerri, MD, Professor
      • Monza, Italia, 20900
        • Respiratory Unit - IRCCS San Gerardo dei Tintori Foundation, Monza
        • Contatto:
        • Investigatore principale:
          • Fabrizio Luppi, MD, Professor
      • Naples, Italia, 80131
        • Interventional Pulmonology Unit, Department of Pulmonology, Oncology and Hematology, Antonio Cardarelli Hospital, Naples, Italy
        • Investigatore principale:
          • Nadia Corcione, MD
        • Contatto:
      • Naples, Italia, 80138
        • Unit of Respiratory Medicine "L. Vanvitelli", A.O. dei Colli, Monaldi Hospital, Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy
        • Contatto:
        • Investigatore principale:
          • Fabio Perrotta, MD, Professor
      • Siena, Italia, 53100
        • Respiratory Unit, Santa Maria alle Scotte University Hospital, Siena
        • Contatto:
        • Investigatore principale:
          • Paolo Cameli, MD, Professor
    • Lombardy
      • Milan, Lombardy, Italia, 20162
        • Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy), Milano, Lombardia 20142
        • Contatto:
        • Sub-investigatore:
          • Jacopo Cefalo, MD
        • Contatto:
        • Sub-investigatore:
          • Marta Italia, MD
        • Sub-investigatore:
          • Giulia Carone, MD
        • Investigatore principale:
          • Michele Mondoni, MD, Professor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients ≥18 years old with interstitial lung disease who need to undergo bronchoscopy for diagnostic purposes, at the time of the first diagnosis or during follow-up (included in the work-up of an acute exacerbation). During the study period, individual patients may undergo more than one bronchoscopic procedure (e.g., for initial diagnostic purposes or for subsequent clinical indications such as disease exacerbation). Therefore, each procedure will be considered as a separate observation for safety analysis.

Descrizione

Inclusion Criteria:

  • Consecutive adult (≥18 years old) patients with suspected or confirmed ILD who need to undergo bronchoscopy as part of their routine clinical practice,
  • Patients able to understand and sign an informed consent

Exclusion Criteria:

  • Patients who refused the study partecipation;
  • Patients with contraindications to bronchoscopy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Patients ≥18 years old with ILD who need to undergo bronchoscopy for diagnostic purpose
Patients ≥18 years old with interstitial lung disease who need to undergo bronchoscopy for diagnostic purposes, at the time of the first diagnosis or during follow-up (included in the work-up of an acute exacerbation).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall rate of complications occurring 30 days after bronchoscopy in patients with ILDs
Lasso di tempo: 30 days
To assess the overall rate of complications occurring 30 days after bronchoscopy in patients with Interstitial Lung Diseases undergoing the endoscopic examination for diagnostic purposes, at the time of the first diagnosis or during follow-up (included in the work-up of an acute exacerbation).
30 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate and type of complications occurring during a single sampling technique or techniques combination (e.g. bronchoscopy with BAL and TBLB)
Lasso di tempo: 30 days
Evaluation of the incidence and type of complications associated with individual or combined bronchoscopic sampling techniques performed during the same examination, (e.g. bronchoalveolar lavage (BAL) combined with transbronchial lung biopsy (TBLB)). The analysis aims to determine whether the use of multiple sampling procedures during a single bronchoscopic session is associated with a different safety profile compared with standalone techniques.
30 days
Rate and type of complications occurring within 24 hours after bronchoscopy
Lasso di tempo: 24 hours
Compications will be assessed for single sampling technique or combination of different techniques
24 hours
Rate and type of complications occurring during the endoscopic procedure, within 24 hours and 30 days after bronchoscopy, at the time of the first ILD diagnosis Vs. during the follow-up
Lasso di tempo: Within 24 hours and at 30 days
Assessment of the incidence, timing, and nature of complications occurring during bronchoscopy, within the first 24 hours, and up to 30 days after the procedure, comparing patients undergoing bronchoscopy at the time of initial ILD diagnosis with those undergoing the procedure during disease follow-up. The analysis aims to evaluate whether the clinical context and stage of disease management influence the safety profile of bronchoscopic procedures in ILD patients.
Within 24 hours and at 30 days
Rate and type of complications occurring during the endoscopic procedure, within 24 hours and 30 days after bronchoscopy in case of suspected/diagnosed AE.
Lasso di tempo: Within 24 hours and at 30 days
Assessment of the incidence, timing, and type of complications occurring during bronchoscopy, within the first 24 hours, and up to 30 days after the procedure in patients undergoing endoscopic evaluation for suspected or confirmed acute exacerbation of interstitial lung disease (AE-ILD). This analysis aims to investigate the safety profile of bronchoscopy in the setting of acute respiratory deterioration, a clinical condition often associated with increased frailty and higher risk of adverse events.
Within 24 hours and at 30 days
Comparison of rate and type of complications among non-exacerbated fibrotic Vs. non-fibrotic ILDs
Lasso di tempo: 30 days
Comparison of the incidence and type of bronchoscopy-related complications between patients with non-exacerbated fibrotic ILDs and those with non-fibrotic ILDs, in order to evaluate whether the underlying radiological and pathological pattern of interstitial lung disease may influence the safety profile of endoscopic procedures.
30 days
Difference in rate and type of complications analysed for single sampling technique using as severity scale The Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (MedDRA 28.0)
Lasso di tempo: 30 days
Comparison of the incidence and severity of complications according to the specific bronchoscopic sampling technique performed, in order to evaluate the safety profile associated with each individual diagnostic procedure. Severity of complications will be assessed using The Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (MedDRA 28.0).
30 days
Rate and type of complications related to the respiratory support and type of sedation
Lasso di tempo: 30 days
Evaluation of the incidence and type of bronchoscopy-related complications according to the modality of respiratory support administered during the procedure, including low-flow oxygen therapy, high-flow nasal cannulas, Venturi mask, non-invasive ventilation, and invasive mechanical ventilation, as well as according to the type of sedation or anaesthesia employed, including conscious sedation, deep sedation, and general anaesthesia. This analysis aims to investigate the potential impact of ventilatory support and sedation strategies on procedural safety in patients with ILD.
30 days
Overall complications rate in patients <80 years old Vs ≥80 years old
Lasso di tempo: 30 days
Comparison of the overall rate of bronchoscopy-related complications between patients younger than 80 years and those aged 80 years or older, in order to assess the impact of advanced age on the safety of endoscopic procedures in ILD patients.
30 days
Comparison of complications rate between patients with and without chronic respiratory failure with ILD who underwent bronchoscopy
Lasso di tempo: 30 days
Comparison of the incidence of bronchoscopy-related complications between patients with interstitial lung disease (ILD) with chronic respiratory failure and those without chronic respiratory failure, in order to evaluate whether the presence of long-standing ventilatory impairment is associated with an increased procedural risk and a different safety profile of endoscopic techniques.
30 days
Comparison of complications rate between patients with FVC <80% and ≥80% of predicted value
Lasso di tempo: 30 days
Comparison of the incidence of bronchoscopy-related complications between patients with interstitial lung disease stratified according to forced vital capacity (FVC), comparing those with FVC <80% of the predicted value versus those with FVC ≥80%, in order to assess whether the degree of ventilatory functional impairment is associated with differences in procedural safety.
30 days
Rate and type of complications occurring during the endoscopic procedure when used for therapeutic purposes in patients with ILD
Lasso di tempo: 30 days
Assessment of the incidence, timing, and nature of complications occurring during bronchoscopy when performed for therapeutic purposes in patients with interstitial lung disease, in order to characterize the safety profile of interventional endoscopic procedures in this specific clinical setting.
30 days
Need for respiratory support escalation following bronchoscopy
Lasso di tempo: 30 days
Evaluation of the need for escalation of respiratory support following bronchoscopy in patients with interstitial lung disease, including progression from baseline oxygen supplementation or ventilatory assistance to more intensive modalities.
30 days
Diagnostic yield of bronchoscopy in patients with ILD (i.e. number of patients for whom bronchoscopy has provided a definite diagnosis of specific ILD or alternative diagnosis).
Lasso di tempo: 30 days
Evaluation of the diagnostic yield of bronchoscopy in patients with interstitial lung disease, defined as the proportion of cases in which the procedure leads to a definitive diagnosis, either confirming a specific ILD subtype or identifying alternative clinically relevant conditions such as lower respiratory tract infection or malignancy. This outcome aims to quantify the overall diagnostic effectiveness of bronchoscopic evaluation in this patient population.
30 days
Comparison of complications rate between patients with Eastern Cooperative Group Performance Status (ECOG-PS) <2 and ≥2
Lasso di tempo: 30 days

Comparison of the incidence of bronchoscopy-related complications between patients with interstitial lung disease stratified according to functional performance status, specifically between those with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) <2 and those with ECOG-PS ≥2, in order to assess whether a poorer baseline functional status is associated with an increased procedural risk and a different safety profile of bronchoscopy.

The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) is a standardized clinical scale used to assess a patient's functional status, level of independence, and ability to perform activities of daily living. It is widely employed in cancer clinical practice and research to evaluate prognosis, treatment eligibility, tolerance to systemic therapy, and overall disease burden.

The ECOG-PS scale ranges from 0 to 5, with increasing scores indicating progressive functional impairment.
30 days
30-day hospitalization rate after bronchoscopy
Lasso di tempo: 30 days
Assessment of hospitalization rate following bronchoscopy in patients with interstitial lung disease, in order to evaluate short-term post-procedural clinical outcomes and overall safety of the endoscopic procedure in this population.
30 days
Regression logistic analysis of the main clinical, demographic, functional, radiological and procedural variables potentially related to the presence of complications.
Lasso di tempo: 30 days
Assessment of the main clinical, demographic, functional, radiological, and procedural characteristics associated with the occurrence of bronchoscopy-related complications in patients with interstitial lung disease through univariate and multivariate analysis, aiming to identify potential factors that may be linked to an increased risk of adverse events.
30 days
30 days mortality rate after bronchoscopy
Lasso di tempo: 30 days
Assessment of 30-days mortality rate following bronchoscopy in patients with interstitial lung disease, in order to evaluate short-term post-procedural clinical outcomes and overall safety of the endoscopic procedure in this population.
30 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Milan

Investigatori

  • Investigatore principale: Michele Mondoni, MD, University of Milan

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

30 maggio 2028

Completamento dello studio (Stimato)

30 maggio 2028

Date di iscrizione allo studio

Primo inviato

15 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SaBrILD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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