Utility of Bronchoscopy in Patients With Haemoptysis and Negative Chest CT Scan (ULYSSES)
ConditionHemoptysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Milan
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Haemoptysis of unknown origin
Negative or non-diagnostic chest CT scan
Disqualifiers
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
Trial population
Adult patients (i.e., ≥18 years) of any nationality (inpatients and outpatients) with haemoptysis of unknown aetiology and negative chest CT scan/with CT scan showing non-diagnostic findings (i.e. focal peripheral lung fibrosis, calcified parenchymal nodules with a maximum diameter \<5 mm, linear subsegmental atelectasis, hilar-mediastinal lymph nodes with a short axis \<1 cm, pleural thickening/pleural calcification and focal area of emphysema with a diameter \<1 cm), in whom bronchoscopy is deemed necessary to obtain an aetiological diagnosis.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Bronchoscopy
Procedure/SurgeryDuring bronchoscopy endobronchial biopsy, transbronchial biopsy, transbronchial needle aspiration, bronchial washing, bronchoalveolar lavage, EBUS-TBNA and EUS-B-FNA may be performed
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Patients with haemoptysis and negative/non-diagnostic CT scan1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
One yearSecondary outcomes
1
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)
Time frame
One year2
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
Time frame
One year3
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
Time frame
One year4
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
Time frame
One yearSponsors and contacts
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Source ClinicalTrials.gov