NCT06935695RecruitingNot Applicable
Surveillance Versus Prn bronChOscoPy aftEr aIrway stenTing (SCOPE-IT)
Icahn School of Medicine at Mount Sinai1 site in 1 country50 target enrollmentStarted: January 1, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of stent-related complications warranting an intervention
Study Overview
Brief Summary
Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Surveillance Group
Experimental
Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion.
Intervention: Bronchoscopy (Device)
No Surveillance
Active Comparator
Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications.
Intervention: Bronchoscopy (Device)
Outcomes
Primary Outcomes
Number of stent-related complications warranting an intervention
Time Frame: 3 months after enrollment
Possible complications: Stent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention
Secondary Outcomes
- Protocol Feasibility Composite Score(3 months after enrollment)
- Number of unscheduled visits due to stent-related complications(3 months after enrollment)
- Number of hospitalizations due to stent-related complications(3 months after enrollment)
- Number of urgent care or emergency room visits due to stent-related complications(3 months after enrollment)
- Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging(3 months after enrollment)
Investigators
Udit Chaddha
Associate Professor of Medicine
Icahn School of Medicine at Mount Sinai
Study Sites (1)
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