Surveillance Versus Bronchoscopy After Airway Stenting

Not Applicable

Recruiting

• Conditions: Bronchial Stents

• Registration Number: NCT06935695
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All adult patients that undergo central airway (trachea, main stem bronchi and bronchus intermedius) stenting.

Exclusion Criteria

• Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment.
• Lobar or segmental stents alone
• Terminally ill patients considered too sick to undergo a follow-up surveillance bronchoscopy
• Stent insertion as a trial for excessive central airway collapse (as the duration of these stents is only 1-2 weeks)
• Patients with a tracheostomy (as these patients can undergo frequent in-line suctioning that can affect the outcomes being assessed)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of stent-related complications warranting an intervention	3 months after enrollment	Possible complications: Stent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention

Secondary Outcome Measures

Name	Time	Method
Protocol Feasibility Composite Score	3 months after enrollment	A composite score comprised from recruitment success (enrollment of target participant numbers), protocol adherence, data completeness, intervention safety, and resource availability to measure protocol feasibility. The total scale for the composite score is 1 to 5, with higher score indicating more feasibility.
Number of unscheduled visits due to stent-related complications	3 months after enrollment	Number of unscheduled visits due to stent-related complications
Number of hospitalizations due to stent-related complications	3 months after enrollment	Number of hospitalizations due to stent-related complications
Number of urgent care or emergency room visits due to stent-related complications	3 months after enrollment	Number of urgent care or emergency room visits due to stent-related complications
Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging	3 months after enrollment	Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging

Trial Locations

Locations (1)

The Mount Sinai Health System; 🇺🇸 New York, New York, United States