Tracheal StenosisSTROBENCT04674995
Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis
An observational study of Tracheal Stenosis, run by University of Modena and Reggio Emilia.
Trial summary
This is a retrospective, observational cohort study carried out in two operative Units of the University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheal Stenosis
- What is being tested?
- Stent placement
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2012to 1 Dec 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We collected clinical, endoscopic and radiological data of patients with benign tracheal stenosis admitted in two operative Units of the University Hospital of Modena (Italy): The Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B) from November 2012 to November 2017
Who may be able to join
- age >18 years,
- exclusion from resection-anastomosis surgery after multidisciplinary evaluation,
- Cotton Meyer > grade II,
- follow-up of at least 3 years after endoscopic surgery,
- no previous tracheal surgery.
Who cannot join
- age > 80,
- stent intolerance which requires removal in the first year after endoscopic treatment,
- performance status > 2,
- end-stage chronic pulmonary disease,
- life-threatening stenosis that needs urgent endoscopic treatments,
- any neoplastic stenosis of the airways,
- dynamic etiology of tracheal benign stenosis (excessive dynamic airway collapse, tracheobronchomalacia).
About this study
This is a retrospective, observational cohort study carried out in two operative Units of the University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B). The two units have different protocols routinely applied to treat tracheal benign stenosis. In Unit A, endoscopic treatment is performed through mechanical dilatation via rigid bronchoscopy and further stent placing while in Unit B the endoscopic treatment is performed through balloon dilatation via direct laryngoscopy. The primary purpose was to compare the efficacy of the two technique on tracheal stenosis treatment over time. Patients were defined as "cured" if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.
- Conditions
- Tracheal Stenosis
- Being tested
- Stent placement
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent placementProcedure or surgery
All interventional procedures have been performed in the operating room with a Dumon rigid bronchoscope under general anesthesia. Neodymium-doped yttrium aluminium garnet laser photoresection was performed at 15-30 watts and pulse duration of 0.5-1.0s whenever indicated. A silicone stent was placed.
| Study group | Role | What they receive |
|---|---|---|
| Stent | Patients with tracheal stenosis treated with stent placement via rigid bronchoscopy. Receives: Procedure: Stent placement | |
| Balloon dilatation | Patients with tracheal stenosis treated with balloon dilatation via laryngoscope. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-stenosis rate over time
Patients were defined as cured if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Nov 2012
- Primary completion1 Nov 2017
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal StenosisStudies 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
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Marchioni, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674995
- Sponsor's protocol ID
- UModenaReggio18
- Acronym
- STROBE
- Status last verified
- Mar 2022
- First submitted
- 14 Dec 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis
- ClinicalTrials.gov ID
- NCT04674995
- Acronym / sponsor ID
- STROBE / UModenaReggio18
- Conditions
- Tracheal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 19 Dec 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.
This is a retrospective, observational cohort study carried out in two operative Units of the University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B). The two units have different protocols routinely applied to treat tracheal benign stenosis. In Unit A, endoscopic treatment is performed through mechanical dilatation via rigid bronchoscopy and further stent placing while in Unit B the endoscopic treatment is performed through balloon dilatation via direct laryngoscopy. The primary purpose was to compare the efficacy of the two technique on tracheal stenosis treatment over time. Patients were defined as "cured" if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent | – | Procedure: Stent placementPatients with tracheal stenosis treated with stent placement via rigid bronchoscopy. |
| Balloon dilatation | – | –Patients with tracheal stenosis treated with balloon dilatation via laryngoscope. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We collected clinical, endoscopic and radiological data of patients with benign tracheal stenosis admitted in two operative Units of the University Hospital of Modena (Italy): The Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B) from November 2012 to November 2017
Key inclusion criteria (5 listed)
- age >18 years,
- exclusion from resection-anastomosis surgery after multidisciplinary evaluation,
- Cotton Meyer > grade II,
- follow-up of at least 3 years after endoscopic surgery,
- no previous tracheal surgery.
Key exclusion criteria (7 listed)
- age > 80,
- stent intolerance which requires removal in the first year after endoscopic treatment,
- performance status > 2,
- end-stage chronic pulmonary disease,
- life-threatening stenosis that needs urgent endoscopic treatments,
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 |
|---|---|---|
| Stent placementAll interventional procedures have been performed in the operating room with a Dumon rigid bronchoscope under general anesthesia. Neodymium-doped yttrium aluminium garnet laser photoresection was performed at 15-30 watts and pulse duration of 0.5-1.0s whenever indicated. A silicone stent was placed. | Procedure or surgery | Stent |
Primary outcome
Re-stenosis rate over time
Time frame: 36 months
Patients were defined as cured if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.
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 4 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Stenosis, run by University of Modena and Reggio Emilia.
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 5 inclusion and 7 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Re-stenosis rate over time (time frame: 36 months). 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 4 Apr 2022.