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

2026年5月29日更新者：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.

調査の概要

状態

まだ募集していません

条件

研究の種類

観察的

入学 (推定)

427

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Michele Mondoni, MD
電話番号：+39 0281843025
メール：michele.mondoni@unimi.it

研究連絡先のバックアップ

名前：Jacopo Cefalo, MD
電話番号：+39 0281843025
メール：michele.mondoni@unimi.it

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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).

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Overall rate of complications occurring 30 days after bronchoscopy in patients with ILDs 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Rate and type of complications occurring during a single sampling technique or techniques combination (e.g. bronchoscopy with BAL and TBLB) 時間枠：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 時間枠：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 時間枠：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. 時間枠：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 時間枠：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) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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). 時間枠：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 時間枠：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 時間枠：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. 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Milan

捜査官

主任研究者：Michele Mondoni, MD、University of Milan

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2028年5月30日

研究の完了 (推定)

2028年5月30日

試験登録日

最初に提出

2026年5月15日

QC基準を満たした最初の提出物

2026年5月29日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)