Clearing blocked airways: A Dutch study on a new bronchoscopy treatment
| ISRCTN | ISRCTN15971199 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15971199 |
- Submission date
- 31/01/2025
- Registration date
- 28/02/2025
- Last edited
- 13/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Central airway obstruction occurs in the trachea and main bronchi and can occur due to malignant and non-malignant causes. It can lead to severe respiratory symptoms. Treatment is often physician-dependent due to a lack of standardized guidelines. This study aims to systematically document the clinical, anatomical, and procedural characteristics of central airway obstruction patients undergoing therapeutic bronchoscopy in the Netherlands. Secondary objectives include evaluating procedure-related complications and identifying prognostic factors.
Who can participate?
Patients diagnosed with central airway obstruction who require therapeutic bronchoscopy, as determined by their treating physician, will be eligible for inclusion. Both flexible and rigid bronchoscopies will be considered.
What does the study involve?
Participants will undergo bronchoscopy, with data collection including patient demographics, obstruction characteristics, treatment details and outcomes. The study will follow standardized definitions and protocols to ensure consistency across participating centers.
What are the possible benefits and risks of participating?
This is a registry study that will document the possible benefits and risks based on real-life data.
Where is the study run from?
The study will be conducted across eight Dutch interventional pulmonology centers, including Amsterdam UMC, Antoni van Leeuwenhoek Hospital, Radboud UMC, Amphia Hospital, UMC Groningen, Erasmus MC, Maastricht UMC and Leiden UMC.
When is the study starting and how long is it expected to run for?
January 2025 to February 2026. The study will start recruiting on February 1st, 2025, and run for 12 months, followed by three months for data analysis and publication.
Who is funding the study?
The study is institutionally approved and governed by The Netherlands Cancer Institute - Antoni van Leeuwenhoekziekenhuis (NKI-AVL)
Who is the main contact?
Dr. I. Smesseim, i.smesseim@nki.nl
Contact information
Principal Investigator
Netherlands Cancer Institute
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
| Phone | +31 20 512 9111 |
|---|---|
| s.burgers@nki.nl |
Public, Scientific
Netheralnds Cancer Institute
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
| Phone | +31 20 512 9111 |
|---|---|
| i.smesseim@nki.nl |
Study information
| Study design | Multicenter observational prospective registry study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Therapeutic bronchoscopy for central airway obstructions: a Dutch multicenter prospective registry study (NVALT36) |
| Study acronym | NVALT36 |
| Study objectives | To describe the clinical, anatomical, and procedural characteristics of CAO patients treated with therapeutic bronchoscopy |
| Ethics approval(s) |
Approved 27/01/2025, Institutional Review Board (IRB) of The Netherlands Cancer Institute (Plesmanlaan 121, Amsterdam, 1066 CX, Netherlands; +31 (0)20 51291; IRB@nki.nl), ref: IRBd23-334 |
| Health condition(s) or problem(s) studied | Central airway obstruction (defined as an obstruction in the trachea, right or left main bronchus, or bronchus intermedius on imaging or by direct visualization during bronchoscopy) necessitating therapeutic bronchoscopy |
| Intervention | When the patient gives consent to participate in the study, only information (patient characteristics, demographics, airway obstruction characteristics and symptoms, procedure, characteristics of airway obstruction and symptoms) will be recorded. The patient will not receive any additional treatment and will not notice anything further from participating in the study. Data analyses Differences between groups will be estimated using chi-square, Fisher’s exact, and independent two-sample t-tests. The chi-square test and Fisher’s test will be used to compare the incidence of complications between two or more groups. A multivariate logistic regression model will be performed using logistic regression to identify prognostic factors associated with procedure-related complications. |
| Intervention type | Other |
| Primary outcome measure | Clinical, anatomical, and procedural characteristics at baseline of patients with central airway obstruction treated with therapeutic bronchoscopy measured using data collected during the procedure at one timepoint |
| Secondary outcome measures | The following secondary outcome measures are assessed using data collected during the procedure at one timepoint: 1. Procedure-associated complications 2. Prognostic factors associated with the procedure |
| Overall study start date | 01/01/2025 |
| Completion date | 01/02/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 500 |
| Key inclusion criteria | 1. Central airway obstruction (defined as obstruction in the trachea, right or left main bronchus, or bronchus intermedius on imaging or by direct visualization during bronchoscopy) as determined by the treating physician necessitating therapeutic bronchoscopy 2. Adults (≥16 years) |
| Key exclusion criteria | <16 years |
| Date of first enrolment | 01/02/2025 |
| Date of final enrolment | 01/02/2026 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Amsterdam
1066 CX
Netherlands
Groningen
9713 GZ
Netherlands
Nijmegen
6525 GA
Netherlands
Amsterdam
1081 HV
Netherlands
Breda
4818 CK
Netherlands
Leiden
2333 ZA
Netherlands
Maastricht
6229 HX
Netherlands
Rotterdam
3015 GD
Netherlands
Sponsor information
Hospital/treatment centre
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
| Phone | +31 20 512 9111 |
|---|---|
| not@available.com | |
| Website | https://www.nki.nl |
"ROR" |
https://ror.org/03xqtf034 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. I. Smesseim, i.smesseim@nki.nl. Data management plan • What data are you going to collect? The data we want to collect are as follows: Age, gender, comorbidities, smoking history, pack years, ECOG performance status, cause of interventional pulmonology procedure, cause of central airway obstruction, type of airway obstruction, respiratory symptoms, MRX dyspnea scale, emergency of procedure, type of anesthesia, type of ventilation during the procedure, type of bronchoscope, Meyer Cottons stenosis grade, debulking technique, complications during the procedure, complications within 24hrs, stent placement, stent material, stent shape, stent characteristics, procedure time. • Where and how are you going to store your data? All participating center will register the information in a national database (Castor) • Who will have access to your data? When? How will you manage that access? The researcher from AVL and the Principal Investigator (PI) will have access to the data. • Which data will be archived at the end of the project? Where, and for how long? The previously mentioned data that we want to collect (see the first question) will be archived for ten years after the publication of the data. • Will the archived data become available to others? When? Under which license? The archived data will not be available to others. If there is a new research question that requires (part of) the database to be used, we expect a physician-researcher from AVL to submit a new IRB application clearly describing the data they wish to use. This must be evaluated by the IRB. • Who is the owner of your data? Who is responsible for managing your data? The researcher (NKI) and principal investigator of the study (NKI) • Which resources are needed for this plan? Castor Database |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 13/02/2025 | No | No |
Additional files
Editorial Notes
13/02/2025: Study's existence confirmed by the Institutional Review Board (IRB) of The Netherlands Cancer Institute.
