NCT06275269

Brief 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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

March 10, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

February 17, 2024

Last Update Submit

February 7, 2025

Conditions

Subglottic Stenosis

Keywords

Subglottic StenosisTriamcinoloneTranslaryngeal Endoscopic Mucosal InjectionUltrasound-Guided Injection

Outcome Measures

Primary Outcomes (1)

  • Incidence of Short-Term Postoperative Complications

    Follow-up on short-term postoperative complications (including pneumothorax, bleeding, wound infection, pain, fever, etc.)

    one week after intervention

Secondary Outcomes (1)

  • Overall medical expenses incurred by patients

    one week after intervention

Study Arms (2)

Ultrasound-Guided Triamcinolone Injection Treatment Group

EXPERIMENTAL

Ultrasound-Guided Triamcinolone Injection for the Treatment of Subglottic Stenosis

Procedure: Ultrasound-Guided

Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group

EXPERIMENTAL

Translaryngeal Endoscopic Mucosal Injection for the Treatment of Subglottic Stenosis

Procedure: Translaryngeal Endoscopic Mucosal Injection

Interventions

Ultrasound-GuidedPROCEDURE

Ultrasound-Guided Triamcinolone Injection

Ultrasound-Guided Triamcinolone Injection Treatment Group
Translaryngeal Endoscopic Mucosal InjectionPROCEDURE

Translaryngeal Endoscopic Mucosal Injection of Triamcinolone

Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • : "Diagnosed with subglottic stenosis through laryngoscopic examination or imaging studies such as CT."
  • : "Experiencing symptoms related to subglottic stenosis, such as breathing difficulties, hoarseness, etc."

You may not qualify if:

  • : "Severe cardiopulmonary dysfunction, patients extremely debilitated and unable to tolerate the procedure."
  • : "Patients allergic to lidocaine, midazolam, triamcinolone, or any of their components."
  • : "Pregnant or lactating women."
  • : "Unstable angina, congestive heart failure, severe bronchial asthma."
  • : "Severe hypertension and arrhythmias, hemodynamically unstable, and severe respiratory failure (PaO2 \<60mmHg after oxygen therapy or mechanical ventilation)."
  • : "Known coagulation dysfunction, inability to stop anticoagulants, antiplatelet agents, aspirin, or nonsteroidal anti-inflammatory drugs before treatment."
  • : "Patients do not agree to participate in this study."
  • : "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Central Study Contacts

Gang Hou, PI

CONTACT

01084206250hougangcmu@163.com

Mingming Deng, Phd

CONTACT

18801336854isdeng1017@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2024

First Posted

February 23, 2024

Study Start

March 10, 2024

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)