Utility of Bronchoscopy in Patients With Haemoptysis and Negative Chest CT Scan

Hemoptysis Clinical Trial

Official title:

Observational, Prospective, Multicentre Study on the Utility of Bronchoscopy in Patients With Haemoptysis and Negative Chest CT Scan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634200
• Other study ID #: BrHaemoCTNeg
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: July 2023
• Source: University of Milan
• Contact: Michele Mondoni, MD
• Phone: 0039 0281843025
• Email: michele.mondoni[@]asst-santipaolocarlo.it; michele.mondoni[@]unimi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Conflicting evidence exist in the literature on the utility of bronchoscopy in patients with haemoptysis and negative/non-diagnostic chest CT scan.

The primary aim of this prospective, observational, multicenter study is to evaluate the utility of bronchoscopy in patients with haemoptysis and negative/non-diagnostic CT scans. Secondary aims are related to the utility of bronchoscopy to detect occult malignancies, the source of the bleeding and the clinical features of the cohort

Description:

Haemoptysis, i.e., coughing up blood from the airways, is a common and alarming symptom in the context of respiratory diseases. Studies conducted in Europe and North America in the last ten years have identified lung cancer (13.9-30.3%), bronchiectasis (6-21%) and low respiratory tract infection (4.2-40%) as the most common causes of the symptom. No international guidelines exist suggesting the optimal diagnostic work-up in patients with haemoptysis, based on demographics characteristics, risk factors (such as smoking history) and clinical presentation. The full diagnostic pathway of the symptom includes patient anamnesis, blood tests, chest X-ray, chest computed tomography (CT) scan and bronchoscopy. The 2020 international guidelines of American College of Radiology recommends performing chest CT scan with intravenous (IV) contrast or a CT angiography after the first episode of haemoptysis of any severity. Many studies recommend CT scan before bronchoscopy, underlining the diagnostic complementarity of the tests and the role of tCT as a guide for endoscopic examination. There is conflicting evidence in the literature on the utility of bronchoscopy in patients with a negative CT scan or in cases of CT showing non-specific or non-diagnostic benign findings (e.g., calcified parenchymal nodule, linear subsegmental atelectasis, pleural thickening). Due to this conflicting evidence, we deem necessary to conduct a prospective, observational, multicentre study. The primary aim is to evaluate the proportion of patients with haemoptysis and negative/non-diagnostic CT scans in whom bronchoscopy allows an aetiological (i.e., endoscopic and/or microbiological and/or anatomopathological) diagnosis.

The secondary objectives are:

• to evaluate the proportion of patients in whom bronchoscopy may detect occult endobronchial neoplasms (not detected with chest CT scan)

• to evaluate the proportion of patients in whom bronchoscopy may identify the source of the bleeding

• to evaluate the proportion of patients with haemoptysis and negative chest CT scan in whom bronchoscopic findings may induce variation in the treatment of the patients

• to evaluate the proportion of patients with a negative bronchoscopy at baseline, in whom a subsequent endoscopic examination performed during the follow-up for recurrent haemoptysis may allow an aetiological (endoscopic and/or microbiological and/or anatomopathological) diagnosis

• to evaluate the proportion of patients with negative CT scan and bronchoscopy in whom lung cancer may be diagnosed during the follow-up

• to evaluate the main clinical characteristics (e.g., severity, duration of haemoptysis) of patients with haemoptysis with negative chest CT scan and bronchoscopy, the rate and severity of symptom recurrence and the mortality rate after one year of follow-up in this cohort.

The study will be performed in twelve Respiratory Units throughout Europe. The study will last two years, and it is estimated to enroll at least 150 adult patients of any nationality referred for haemoptysis of unknown origin with negative/non-diagnostic chest CT scan, for whom bronchoscopy is deemed necessary to obtain an aetiological diagnosis. Patients will undergo pulmonary examination and blood tests (complete blood count, PT, PTT, urea, blood creatinine and CRP) before bronchoscopy. A chest CT scan with IV contrast is considered necessary, except for patients with absolute contraindications (renal failure, allergy to iodinate IV contrast). Only patients with chest CT scan performed within 72 hours from the last episode of haemoptysis will be enrolled in the study. Bronchoscopy will be performed within two weeks of the chest CT scan. All the enrolled patients will be followed-up for 12 months with a telephone interview at one, three, six and twelve months after the enrolment. In case of haemoptysis relapse, a clinical evaluation could be performed. Each centre will decide upon the subsequent diagnostic work-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years old

• Haemoptysis of unknown origin

• Negative or non-diagnostic chest CT scan

Exclusion Criteria:

• Known bleeding lesions of the upper or lower respiratory airways

• Chest CT scan diagnostic for hemoptysis etiology

• Refusal to sign the informed consent

• Refusal of bronchoscopy

Related Conditions & MeSH terms

• Hemoptysis

Intervention

Procedure:
• Bronchoscopy
During bronchoscopy endobronchial biopsy, transbronchial biopsy, transbronchial needle aspiration, bronchial washing, bronchoalveolar lavage, EBUS-TBNA and EUS-B-FNA may be performed

Locations

Country	Name	City	State
Italy	- Respiratory Unit, ASST Papa Giovanni XVIII	Bergamo
Italy	- Interventional Pulmonology Unit, Policlinico S. Orsola-Malpighi	Bologna
Italy	Department of Pulmonary and Critical Care Medicine, Sant'Anna Hospital	Como
Italy	Respiratory Unit, ASST Lodi	Lodi
Italy	- Respiratory Unit, Sacco Hospital, ASST Fatebenefratelli-Sacco	Milan
Italy	Respiratory Unit, ASST Santi Paolo e Carlo	Milan
Italy	Respiratory Unit, San Gerardo Hospital, ASST Monza	Monza
Italy	Interventional Pulmonology Unit, Dept of Pulmonology, Oncology and Hematology, Cardarelli Hospital	Naples
Italy	- Respiratory Unit, IRCCS Foundation Policlinico San Matteo	Pavia
Italy	Pulmonology Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia	Reggio Emilia
Italy	- Interventional Pulmonology Unit, Policlinico Agostino Gemelli	Roma
Italy	- Respiratory Unit, A.O.U. Città della Salute e della Scienza di Torino	Torino
Italy	Department of Pulmonology, University Hospital of Udine (ASUFC)	Udine
Spain	Interventional Pulmonology Unit, Respiratory Department, University Hospital Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the proportion of patients with haemoptysis and negative/non-diagnostic CT scans in whom bronchoscopy allows an aetiological (i.e., endoscopic and/or microbiological and/or anatomopathological) diagnosis	The primary aim of the study is to evaluate the proportion of patients with haemoptysis and negative/non-diagnostic CT scans in whom bronchoscopy allows an aetiological (i.e., endoscopic and/or microbiological and/or anatomopathological) diagnosis	One year
Secondary	To evaluate the proportion of patients in whom bronchoscopy may detect occult endobronchial neoplasms (not detected with chest CT scan)	To evaluate the proportion of patients in whom bronchoscopy may detect occult endobronchial neoplasms (not detected with chest CT scan)	One year
Secondary	To evaluate the proportion of patients in whom bronchoscopy may identify the source of the bleeding	To evaluate the proportion of patients in whom bronchoscopy may identify the source of the bleeding	One year
Secondary	To evaluate the proportion of patients with haemoptysis and negative chest CT scan in whom bronchoscopic findings may induce variation in the treatment of the patients	To evaluate the proportion of patients with haemoptysis and negative chest CT scan in whom bronchoscopic findings may induce variation in the treatment of the patients	One year
Secondary	To evaluate the proportion of patients with a negative bronchoscopy at baseline, in whom a an endoscopic examination performed during the follow-up for recurrent haemoptysis may allow an aetiological diagnosis	To evaluate the proportion of patients with a negative bronchoscopy at baseline, in whom a subsequent endoscopic examination performed during the follow-up for recurrent haemoptysis may allow an aetiological (endoscopic and/or microbiological and/or anatomopathological) diagnosis	One year
Secondary	To evaluate the proportion of patients with a negative chest CT scan and bronchoscopy in whom lung cancer may be diagnosed during the follow-up	To evaluate the proportion of patients with a negative chest CT scan and bronchoscopy in whom lung cancer may be diagnosed during the follow-up	One year
Secondary	To evaluate the main clinical characteristics (e.g., severity of haemoptysis) of these patients, the rate and severity of symptom recurrence and the mortality rate after one year of follow-up.	To evaluate the main clinical characteristics (e.g., severity, duration of haemoptysis) of patients with haemoptysis with negative chest CT scan and bronchoscopy, the rate and severity of symptom recurrence and the mortality rate after one year of follow-up in this cohort.	One year