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

2026년 5월 29일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

연구 유형

관찰

등록 (추정된)

427

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall rate of complications occurring 30 days after bronchoscopy in patients with ILDs
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Rate and type of complications occurring during a single sampling technique or techniques combination (e.g. bronchoscopy with BAL and TBLB)
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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).
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Milan

수사관

  • 수석 연구원: Michele Mondoni, MD, University of Milan

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2028년 5월 30일

연구 완료 (추정된)

2028년 5월 30일

연구 등록 날짜

최초 제출

2026년 5월 15일

QC 기준을 충족하는 최초 제출

2026년 5월 29일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 29일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SaBrILD

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다