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

29. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Typ studie

Pozorovací

Zápis (Odhadovaný)

427

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Michele Mondoni, MD
Telefonní číslo: +39 0281843025
E-mail: michele.mondoni@unimi.it

Studijní záloha kontaktů

Jméno: Jacopo Cefalo, MD
Telefonní číslo: +39 0281843025
E-mail: michele.mondoni@unimi.it

Studijní místa

Francie
- - Paris, Francie, 75877
    - - Service de Pneumologie Allergologie et Transplantation, Centre Constitutif du Centre de Référence des Maladies Pulmonaires Rares, FHU INFIRE, Paris, France
    - Kontakt:
      
      Bruno Crestani, MD, Professor
      
      Telefonní číslo: +330140256800
      
      E-mail: bruno.crestani@aphp.fr
    - Vrchní vyšetřovatel:
      
      Bruno Crestani, MD, Professor
Itálie
- - Bologna, Itálie, 38050
    - Respiratory Unit, Azienda Ospedaliera-Universitaria IRCCS Policlinico di Sant'Orsola Malpighi, Bologna, Italy
    - Kontakt:
      
      Piero Candoli, MD
      
      Telefonní číslo: +390512144649
      
      E-mail: piero.candoli@aosp.bo.it
    - Vrchní vyšetřovatel:
      
      Piero Candoli, MD
  - Genova, Itálie, 16132
    - Unit of Pneumology, San Martino Policlinic Hospital, Genoa, Italy
    - Vrchní vyšetřovatel:
      
      Emanuela Barisione, MD
    - Kontakt:
      
      Emanuela Barisione, MD
      
      Telefonní číslo: +390105555801
      
      E-mail: emanuela.barisione@aomliguria.it)
  - Legnano, Itálie, 20025
    - Respiratory Unit - Legnano Hospital, ASST Ovest Milanese
    - Kontakt:
      
      Paolo Carlucci, MD
      
      Telefonní číslo: +390331449926
      
      E-mail: paolo.carlucci@asst-ovestmi.it
    - Vrchní vyšetřovatel:
      
      Paolo Carlucci, MD
  - Milan, Itálie, 20157
    - Division of Respiratory Diseases, Ospedale Luigi Sacco, Polo Universitario, ASST Fatebenefratelli-Sacco
    - Kontakt:
      
      Pierachille Santus, MD, Professor
      
      Telefonní číslo: +390239042875
      
      E-mail: pierachille.santus@unimi.it
    - Vrchní vyšetřovatel:
      
      Pierachille Santus, MD, Professor
  - Modena, Itálie, 41124
    - Respiratory Unit - Center for Rare Lung Disease - Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy
    - Kontakt:
      
      Stefania Cerri, MD, Professor
      
      Telefonní číslo: +390594225335
      
      E-mail: stefycerri@unimore.it
    - Vrchní vyšetřovatel:
      
      Stefania Cerri, MD, Professor
  - Monza, Itálie, 20900
    - Respiratory Unit - IRCCS San Gerardo dei Tintori Foundation, Monza
    - Kontakt:
      
      Fabrizio Luppi, MD, Professor
      
      Telefonní číslo: +390392339040
      
      E-mail: fabrizio.luppi@unimib.it
    - Vrchní vyšetřovatel:
      
      Fabrizio Luppi, MD, Professor
  - Naples, Itálie, 80131
    - Interventional Pulmonology Unit, Department of Pulmonology, Oncology and Hematology, Antonio Cardarelli Hospital, Naples, Italy
    - Vrchní vyšetřovatel:
      
      Nadia Corcione, MD
    - Kontakt:
      
      Nadia Corcione, MD
      
      Telefonní číslo: +390817473391
      
      E-mail: nadia.corcione@gmail.com
  - Naples, Itálie, 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
    - Kontakt:
      
      Fabio Perrotta, MD, Professor
      
      Telefonní číslo: +393288238978
      
      E-mail: fabio.perrotta@unicampania.it
    - Vrchní vyšetřovatel:
      
      Fabio Perrotta, MD, Professor
  - Siena, Itálie, 53100
    - Respiratory Unit, Santa Maria alle Scotte University Hospital, Siena
    - Kontakt:
      
      Paolo Cameli, MD, Professor
      
      Telefonní číslo: +390577235555
      
      E-mail: paolo.cameli@unisi.it
    - Vrchní vyšetřovatel:
      
      Paolo Cameli, MD, Professor
- Lombardy
  - Milan, Lombardy, Itálie, 20162
    - Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy), Milano, Lombardia 20142
    - Kontakt:
      
      Jacopo Cefalo, MD
      
      Telefonní číslo: +390281843025
      
      E-mail: jacopo.cefalo@asst-santipaolocarlo.it
    - Dílčí vyšetřovatel:
      
      Jacopo Cefalo, MD
    - Kontakt:
      
      Marta Italia, MD
      
      Telefonní číslo: +390281843025
      
      E-mail: marta.italia@unimi.it
    - Dílčí vyšetřovatel:
      
      Marta Italia, MD
    - Dílčí vyšetřovatel:
      
      Giulia Carone, MD
    - Vrchní vyšetřovatel:
      
      Michele Mondoni, MD, Professor

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
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).

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Overall rate of complications occurring 30 days after bronchoscopy in patients with ILDs Časové okno: 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

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Rate and type of complications occurring during a single sampling technique or techniques combination (e.g. bronchoscopy with BAL and TBLB) Časové okno: 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 Časové okno: 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 Časové okno: 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. Časové okno: 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 Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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). Časové okno: 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 Časové okno: 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 Časové okno: 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. Časové okno: 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 Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Milan

Vyšetřovatelé

Vrchní vyšetřovatel: Michele Mondoni, MD, University of Milan

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

30. května 2028

Dokončení studie (Odhadovaný)

30. května 2028

Termíny zápisu do studia

První předloženo

15. května 2026

První předloženo, které splnilo kritéria kontroly kvality

29. května 2026

První zveřejněno (Aktuální)

4. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)