Surveillance Versus Bronchoscopy After Airway Stenting (SCOPE-IT)

Mount Sinai Health System

Status: Enrolling

Conditions: Bronchial Stents

Treatments: Device: Bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06935695

STUDY-24-01352

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Surveillance Group

Experimental group

Description:

Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion.

Treatment:

Device: Bronchoscopy

No Surveillance

Active Comparator group

Description:

Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications.

Treatment:

Device: Bronchoscopy