Evaluating bronchoscopy for patients with unexplained coughing up blood and negative CT scans
Utility of Bronchoscopy in Patients With Haemoptysis and Negative Chest CT Scan: an Observational, Prospective, Multicentre Study (ULYSSES)
University of Milan · NCT05634200
This study is testing if a procedure called bronchoscopy can help find the cause of coughing up blood in patients who have had negative chest scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milan (other) |
| Locations | 14 sites (Bergamo and 13 other locations) |
| Trial ID | NCT05634200 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of bronchoscopy in patients who experience haemoptysis but have negative or non-diagnostic chest CT scans. It will involve a multicenter approach, gathering data on the utility of bronchoscopy to identify the source of bleeding and detect any hidden malignancies. The study will also analyze the clinical characteristics of the patient cohort to better understand the implications of these findings. By addressing conflicting evidence in existing literature, this research seeks to clarify the role of bronchoscopy in the diagnostic pathway for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have unexplained haemoptysis and negative or non-diagnostic chest CT scans.
Not a fit: Patients with known bleeding lesions or those whose CT scans have already diagnosed the cause of haemoptysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diagnostic accuracy and treatment options for patients experiencing unexplained haemoptysis.
How similar studies have performed: While there is conflicting evidence regarding the utility of bronchoscopy in similar cases, this study aims to provide new insights into its effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bergamo and 13 other locations
- - Respiratory Unit, ASST Papa Giovanni XVIII — Bergamo, Italy (RECRUITING)
- - Interventional Pulmonology Unit, Policlinico S. Orsola-Malpighi — Bologna, Italy (RECRUITING)
- Department of Pulmonary and Critical Care Medicine, Sant'Anna Hospital — Como, Italy (RECRUITING)
- Respiratory Unit, ASST Lodi — Lodi, Italy (RECRUITING)
- Respiratory Unit, ASST Santi Paolo e Carlo — Milan, Italy (RECRUITING)
- - Respiratory Unit, Sacco Hospital, ASST Fatebenefratelli-Sacco — Milan, Italy (RECRUITING)
- Respiratory Unit, San Gerardo Hospital, ASST Monza — Monza, Italy (RECRUITING)
- Interventional Pulmonology Unit, Dept of Pulmonology, Oncology and Hematology, Cardarelli Hospital — Naples, Italy (RECRUITING)
- - Respiratory Unit, IRCCS Foundation Policlinico San Matteo — Pavia, Italy (ACTIVE_NOT_RECRUITING)
- Pulmonology Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia — Reggio Emilia, Italy (RECRUITING)
- - Interventional Pulmonology Unit, Policlinico Agostino Gemelli — Roma, Italy (RECRUITING)
- - Respiratory Unit, A.O.U. Città della Salute e della Scienza di Torino — Torino, Italy (RECRUITING)
- Department of Pulmonology, University Hospital of Udine (ASUFC) — Udine, Italy (RECRUITING)
- Interventional Pulmonology Unit, Respiratory Department, University Hospital Santa Creu i Sant Pau — Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Michele Mondoni, MD — Respiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital, Milan
- Study coordinator: Michele Mondoni, MD
- Email: michele.mondoni@asst-santipaolocarlo.it; michele.mondoni@unimi.it
- Phone: 0039 0281843025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemoptysis, Computed tomography, Bronchoscopy, Lung cancer, CT scan, Haemoptysis