Complication of BronchoscopyNCT04621344
Complications After Endosonography and Guided Bronchoscopy
An observational study of Complication of Bronchoscopy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The present study aims to investigate prospectively and systematically the direct and indirect complications occurring within 30 days after guided-bronchoscopy and/or endosonography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Bronchoscopy
- What is being tested?
- Guided bronchoscopy and/or endosonography
- How many people
- 701 participants
- Where
- 1 siteItaly
- Study dates
- 27 Oct 2020to 8 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication to guided bronchoscopy, endosonography, or both-
Who may be able to join
- Age >18 years,
- Indication to undergo bronchoscopy, endosonography, or both.
- Signed informed consent
Who cannot join
- Absolute contraindications to the bronchoscopic examination based on international guidelines [31].
- Platelet count <50000
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
About this study
Official title: 30-DAY MORBIDITY, MORTALITY AND UNPLANNED HOSPITAL ADMISSIONS AFTER GUIDED-BRONCHOSCOPY AND ENDOSONOGRAPHY
The present study aims to investigate prospectively and systematically the direct and indirect complications occurring within 30 days after guided-bronchoscopy and/or endosonography. The results of the study should reliably help clarify further incidence, pattern, risk factors, and outcomes for both immediate and late complications associated with these key diagnostic procedures.
- Conditions
- Complication of Bronchoscopy
- Being tested
- Guided bronchoscopy and/or endosonography
- Keywords
- Endosonography, Guided bronchoscopy, Complications, Hospital admission, Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided bronchoscopy and/or endosonographyDiagnostic test
Endoscopic procedures aimed at sampling of intrathoracic lymph nodes or pulmonary lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe complications
Measured: 30 days
Secondary outcomes (4)
Overall incidence of complications
Measured: 30 days
Risk factors associated with severe complications
Measured: 30 days
Rate of unplanned hospital admissions
Measured: 30 days
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start27 Oct 2020
- Primary completion7 Feb 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rocco Trisolini, MD, Principal investigator, Fondazione Policlinico Universitario A. Gemelli IRCS, Università Cattolica del Sacro Cuore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621344
- Sponsor's protocol ID
- ST1
- Status last verified
- Apr 2022
- First submitted
- 3 Nov 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 30-DAY MORBIDITY, MORTALITY AND UNPLANNED HOSPITAL ADMISSIONS AFTER GUIDED-BRONCHOSCOPY AND ENDOSONOGRAPHY
- ClinicalTrials.gov ID
- NCT04621344
- Acronym / sponsor ID
- ST1
- Conditions
- Complication of Bronchoscopy
- Keywords
- Endosonography, Guided bronchoscopy, Complications, Hospital admission, Lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to investigate prospectively and systematically the direct and indirect complications occurring within 30 days after guided-bronchoscopy and/or endosonography. The results of the study should reliably help clarify further incidence, pattern, risk factors, and outcomes for both immediate and late complications associated with these key diagnostic procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication to guided bronchoscopy, endosonography, or both-
Key inclusion criteria (3 listed)
- Age >18 years,
- Indication to undergo bronchoscopy, endosonography, or both.
- Signed informed consent
Key exclusion criteria (2 listed)
- Absolute contraindications to the bronchoscopic examination based on international guidelines [31].
- Platelet count <50000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided bronchoscopy and/or endosonographyEndoscopic procedures aimed at sampling of intrathoracic lymph nodes or pulmonary lesions | Diagnostic test | – |
Primary outcome
Incidence of severe complications
Time frame: 30 days
4 secondary outcomes
Overall incidence of complications
Time frame: 30 days
Risk factors associated with severe complications
Time frame: 30 days
Rate of unplanned hospital admissions
Time frame: 30 days
Mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Complication of Bronchoscopy
Not yet recruitingObservational study
The Impact of Preoperative Nasal Capnography on Clinical Management in Patients Undergoing Diagnostic Bronchoscopy for Suspected Foreign Body Aspiration
Foreign Body Aspiration
Recruiting
Influence of Postoperative Bronchoscopy on Pulmonary Complications After Anatomical Lung Resections.
Postoperative Complications, Thoracic Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocco Trisolini, MD principal investigator
Fondazione Policlinico Universitario A. Gemelli IRCS, Università Cattolica del Sacro Cuore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Bronchoscopy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.