Subglottic StenosisNCT06275269
Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis
A study testing Ultrasound-Guided and Translaryngeal Endoscopic Mucosal Injection in people with Subglottic Stenosis, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subglottic Stenosis
- What is being tested?
- Ultrasound-Guided and Translaryngeal Endoscopic Mucosal Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1: "Diagnosed with subglottic stenosis through laryngoscopic examination or imaging studies such as CT."
- 2: "Experiencing symptoms related to subglottic stenosis, such as breathing difficulties, hoarseness, etc."
Who cannot join
- 1: "Severe cardiopulmonary dysfunction, patients extremely debilitated and unable to tolerate the procedure."
- 2: "Patients allergic to lidocaine, midazolam, triamcinolone, or any of their components."
- 3: "Pregnant or lactating women."
- 4: "Unstable angina, congestive heart failure, severe bronchial asthma."
- 5: "Severe hypertension and arrhythmias, hemodynamically unstable, and severe respiratory failure (PaO2 <60mmHg after oxygen therapy or mechanical ventilation)."
- 6: "Known coagulation dysfunction, inability to stop anticoagulants, antiplatelet agents, aspirin, or nonsteroidal anti-inflammatory drugs before treatment."
Show all 9Show fewer
- 7: "Patients do not agree to participate in this study."
- 8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."
- 9: "Researchers believe there are any circumstances making the patient unsuitable for inclusion."
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Mingming Deng, 86 18801336854, isdeng1017@163.com
About this study
Official title: Comparison of the Safety and Economics of Translaryngeal Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone for the Treatment of Subglottic Stenosis: a Multicenter, Randomized Controlled Study.
This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods.
- Conditions
- Subglottic Stenosis
- Being tested
- Ultrasound-Guided, Translaryngeal Endoscopic Mucosal Injection
- Keywords
- Subglottic Stenosis, Triamcinolone, Translaryngeal Endoscopic Mucosal Injection, Ultrasound-Guided Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-GuidedProcedure or surgery
Ultrasound-Guided Triamcinolone Injection
Translaryngeal Endoscopic Mucosal InjectionProcedure or surgery
Translaryngeal Endoscopic Mucosal Injection of Triamcinolone
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Triamcinolone Injection Treatment Group | Experimental | Ultrasound-Guided Triamcinolone Injection for the Treatment of Subglottic Stenosis Receives: Procedure: Ultrasound-Guided |
| Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group | Experimental | Translaryngeal Endoscopic Mucosal Injection for the Treatment of Subglottic Stenosis Receives: Procedure: Translaryngeal Endoscopic Mucosal Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Short-Term Postoperative Complications
Follow-up on short-term postoperative complications (including pneumothorax, bleeding, wound infection, pain, fever, etc.)
Measured: one week after intervention
Secondary outcomes (1)
Overall medical expenses incurred by patients
Overall medical expenses incurred
Measured: one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start10 Mar 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subglottic StenosisStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275269
- Sponsor's protocol ID
- ZRJY2021-BJ08-04-02
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2024
- Last updated
- 10 Feb 2025
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Safety and Economics of Translaryngeal Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone for the Treatment of Subglottic Stenosis: a Multicenter, Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06275269
- Acronym / sponsor ID
- ZRJY2021-BJ08-04-02
- Conditions
- Subglottic Stenosis
- Keywords
- Subglottic Stenosis, Triamcinolone, Translaryngeal Endoscopic Mucosal Injection, Ultrasound-Guided Injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Feb 2024 (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 study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Triamcinolone Injection Treatment Group | Experimental | Procedure: Ultrasound-GuidedUltrasound-Guided Triamcinolone Injection for the Treatment of Subglottic Stenosis |
| Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group | Experimental | Procedure: Translaryngeal Endoscopic Mucosal InjectionTranslaryngeal Endoscopic Mucosal Injection for the Treatment of Subglottic Stenosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1: "Diagnosed with subglottic stenosis through laryngoscopic examination or imaging studies such as CT."
- 2: "Experiencing symptoms related to subglottic stenosis, such as breathing difficulties, hoarseness, etc."
Key exclusion criteria (9 listed)
- 1: "Severe cardiopulmonary dysfunction, patients extremely debilitated and unable to tolerate the procedure."
- 2: "Patients allergic to lidocaine, midazolam, triamcinolone, or any of their components."
- 3: "Pregnant or lactating women."
- 4: "Unstable angina, congestive heart failure, severe bronchial asthma."
- 5: "Severe hypertension and arrhythmias, hemodynamically unstable, and severe respiratory failure (PaO2 <60mmHg after oxygen therapy or mechanical ventilation)."
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 |
|---|---|---|
| Ultrasound-GuidedUltrasound-Guided Triamcinolone Injection | Procedure or surgery | Ultrasound-Guided Triamcinolone Injection Treatment Group |
| Translaryngeal Endoscopic Mucosal InjectionTranslaryngeal Endoscopic Mucosal Injection of Triamcinolone | Procedure or surgery | Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group |
Primary outcome
Incidence of Short-Term Postoperative Complications
Time frame: one week after intervention
Follow-up on short-term postoperative complications (including pneumothorax, bleeding, wound infection, pain, fever, etc.)
1 secondary outcome
Overall medical expenses incurred by patients
Time frame: one week after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided and Translaryngeal Endoscopic Mucosal Injection in people with Subglottic Stenosis, run by China-Japan Friendship Hospital at 1 site in China.
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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Hou, PI (01084206250, hougangcmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Short-Term Postoperative Complications (time frame: one week after intervention). 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 10 Feb 2025.