Trial Title:
Utility of Bronchoscopy in Patients With Haemoptysis and Negative Chest CT Scan (ULYSSES)
NCT ID:
NCT05634200
Condition:
Hemoptysis
Conditions: Official terms:
Hemoptysis
Conditions: Keywords:
Computed tomography
Bronchoscopy
Lung cancer
CT scan
Haemoptysis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Bronchoscopy
Description:
During bronchoscopy endobronchial biopsy, transbronchial biopsy, transbronchial needle
aspiration, bronchial washing, bronchoalveolar lavage, EBUS-TBNA and EUS-B-FNA may be
performed
Arm group label:
Patients with haemoptysis and negative/non-diagnostic CT scan
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
Detailed 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
- Respiratory Unit, ASST Papa Giovanni XVIII
Address:
City:
Bergamo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabiano Di Marco, MD
Email:
fabiano.dimarco@unimi.it
Facility:
Name:
- Interventional Pulmonology Unit, Policlinico S. Orsola-Malpighi
Address:
City:
Bologna
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Pietro Candoli, MD
Email:
pcandoli@libero.it
Facility:
Name:
Department of Pulmonary and Critical Care Medicine, Sant'Anna Hospital
Address:
City:
Como
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Claudio Sorino, MD
Email:
claudio.sorino@asst-lariana.it
Facility:
Name:
Respiratory Unit, ASST Lodi
Address:
City:
Lodi
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Cipolla, MD
Email:
giuseppe.cipolla@asst-lodi.it
Facility:
Name:
Respiratory Unit, ASST Santi Paolo e Carlo
Address:
City:
Milan
Zip:
20142
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Mondoni, MD
Phone:
0039 0281843025
Email:
michele.mondoni@asst-santipaolocarlo.it; michele.mondoni@unimi.it
Contact backup:
Last name:
Giulia Nalesso, MD
Phone:
0039 0281843025
Email:
giulia.nalesso@unimi.it
Facility:
Name:
- Respiratory Unit, Sacco Hospital, ASST Fatebenefratelli-Sacco
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Pierachille Santus, MD
Email:
pierachille.santus@unimi.it
Facility:
Name:
Respiratory Unit, San Gerardo Hospital, ASST Monza
Address:
City:
Monza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabrizio Luppi, MD
Email:
fabrizio.luppi@unimib.it
Facility:
Name:
Interventional Pulmonology Unit, Dept of Pulmonology, Oncology and Hematology, Cardarelli Hospital
Address:
City:
Naples
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Nadia Corcione, MD
Email:
nadia.corcione@gmail.com
Facility:
Name:
- Respiratory Unit, IRCCS Foundation Policlinico San Matteo
Address:
City:
Pavia
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Pulmonology Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Roberto Piro, MD
Email:
roberto.piro@ausl.re.it
Facility:
Name:
- Interventional Pulmonology Unit, Policlinico Agostino Gemelli
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rocco Trisolini, MD
Email:
rocco.trisolini@policlinicogemelli.it
Facility:
Name:
- Respiratory Unit, A.O.U. Città della Salute e della Scienza di Torino
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paolo Solidoro, MD
Email:
psolidoro@cittadellasalute.to.it
Facility:
Name:
Department of Pulmonology, University Hospital of Udine (ASUFC)
Address:
City:
Udine
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alberto Fantin
Email:
alberto.fantin@asufc.sanita.fvg.it
Facility:
Name:
Interventional Pulmonology Unit, Respiratory Department, University Hospital Santa Creu i Sant Pau
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alfons Torrego, MD
Email:
atorrego@santpau.cat
Start date:
October 1, 2022
Completion date:
October 1, 2025
Lead sponsor:
Agency:
University of Milan
Agency class:
Other
Source:
University of Milan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05634200
