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

NCT05634200 | Recruiting DMC

• 1 other identifier: BrHaemoCTNeg
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 14

Brief 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

Conditions

Hemoptysis

Keywords

Computed tomography; Bronchoscopy; Lung cancer; CT scan; Haemoptysis

Outcome Measures

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

  One year

Secondary Outcomes (6)

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

  One year

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

  One year

• 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

• 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

  One year

• 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

Study Arms (1)

Patients with haemoptysis and negative/non-diagnostic CT scan

Patients with haemoptysis and negative/non-diagnostic CT scan (i.e. with 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) for whom bronchoscopy is deemed necessary to obtain an aetiological diagnosis.

Procedure: Bronchoscopy

Interventions

Bronchoscopy PROCEDURE

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

Patients with haemoptysis and negative/non-diagnostic CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• ≥18 years old
• Haemoptysis of unknown origin
• Negative or non-diagnostic chest CT scan

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (14)

- 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, 20142, 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

Biospecimen

Retention: SAMPLES WITH DNA

blood, serum, bronchial/lung tissue, bronchial secretions, BAL fluid, lymph node aspirates

MeSH Terms

Conditions

Hemoptysis; Lung Neoplasms

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Michele Mondoni, MD

  Respiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital, Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Mondoni, MD

CONTACT

0039 0281843025; michele.mondoni@asst-santipaolocarlo.it; michele.mondoni@unimi.it

Giulia Nalesso, MD

CONTACT

0039 0281843025; giulia.nalesso@unimi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Respiratory Medicine

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 2, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

ES (1); IT (13)