Bronchoscopy for Airway Stents

(SCOPE-IT Trial)

Overseen By Axel Duval, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Cognitive impairment, Terminal illness, Tracheostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if regular check-ups using bronchoscopy (a procedure to look inside the lungs) after placing stents in the airways can improve patient outcomes. Participants are divided into two groups: one group undergoes scheduled bronchoscopies a few weeks after receiving the stent, while the other group only undergoes the procedure if they show symptoms of complications. This study targets individuals who have had stents placed in their main airways to address breathing issues. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance future patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that bronchoscopy is safe for airway stents?

Research has shown that bronchoscopy, a procedure to examine the airways, is generally safe for patients with airway stents. Studies have found that airway stents can significantly improve symptoms and quality of life for individuals with blocked airways. One study noted the procedure's safety, with few complications.

Specific risks include minor bleeding or breathing problems, but these are uncommon. In one report, only a few patients experienced minor issues like bleeding or trouble breathing. Additionally, stents are typically easy to insert, and most do not require removal.

Overall, evidence suggests that bronchoscopy is well-tolerated, with only a few patients experiencing mild side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches to managing airway stents through bronchoscopy. The first approach is a proactive surveillance bronchoscopy scheduled 4-6 weeks after stent insertion, which could potentially catch complications early. The second approach relies on bronchoscopy only if symptoms suggest stent-related problems, aiming to reduce unnecessary procedures. This trial could reveal the most effective strategy for balancing patient safety with the invasiveness of the procedure, potentially setting a new standard for post-stent care.

What evidence suggests that bronchoscopy is effective for airway stents?

This trial will compare two approaches: one group of participants will undergo regular surveillance bronchoscopy 4-6 weeks after stent insertion, while another group will have bronchoscopies only if clinical symptoms suggest stent-related complications. Studies have shown that using a bronchoscope to check the airways after placing a stent can help detect problems early. This allows for the early identification of issues such as stent displacement, scar tissue formation, or blockages from mucus. Research indicates that about 33% of patients with stents experience these problems. Early detection through regular checks might make these issues easier to manage. Overall, this approach aims to improve patients' well-being and function after receiving a stent. ^{1 3 6 7 8}

Who Is on the Research Team?

Udit Chaddha, MBBS

Principal Investigator

Icahn School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults who've had a stent placed in their central airways due to medical conditions. Candidates must be able to give informed consent and not have tracheostomies or short-term stents for airway collapse. Those too ill for follow-up procedures are excluded.

Inclusion Criteria

I have had a stent placed in my central airway.

Exclusion Criteria

Lobar or segmental stents alone

I am unable to understand or sign the consent form due to cognitive or mental health issues.

I am too ill for follow-up lung exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tracheobronchial stenting

Immediate

Surveillance

Surveillance bronchoscopy scheduled 4-6 weeks after stent insertion for the experimental group

4-6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for stent-related complications

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Bronchoscopy

Trial Overview The study is testing if it's better to monitor patients with bronchoscopy after they get an airway stent, compared to no monitoring at all. It's a pilot study where participants are randomly chosen to either receive surveillance or not.

How Is the Trial Designed?

Group I: Surveillance Group Experimental Treatment 1 Intervention

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

Group II: No Surveillance Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a 15-month study of 697 patients undergoing advanced diagnostic bronchoscopy, severe complications were rare, occurring in only 2.4% of patients, but they had serious consequences, including unplanned hospital visits and deaths.

Many complications occurred days or weeks after the procedure, highlighting the need for proactive monitoring to identify and manage these delayed adverse events effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirty-Day Complications, Unplanned Hospital Encounters, and Mortality after Endosonography and/or Guided Bronchoscopy: A Prospective Study. Magnini, D., Sotgiu, G., Bello, G., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5721036/

Airway stent complications: the role of follow-up bronchoscopy ... Surveillance bronchoscopy within 4 to 6 weeks of stent placement may be useful for early detection of complications and their subsequent management.

2. nature.com nature.com/articles/s41598-025-97850-2

Prognostic factors and clinical outcomes of stenting on ... Airway stenting is a safe and effective procedure leading to significant improvements in clinical symptoms and QoL for patients with MCAO at a 6-month follow- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06935695

Surveillance Versus Bronchoscopy After Airway Stenting ... Stent insertion as a trial for excessive central airway collapse (as the duration of these stents is only 1-2 weeks)

4. resmedjournal.com resmedjournal.com/article/S0954-6111(25)00218-5/fulltext

Procedure-free survival after therapeutic bronchoscopy in ... The median procedure-free survival was 175 days for benign CAO and 49 days for malignant CAO. Airway prosthetics are linked to shorter procedure-free survival ...

5. mdpi.com mdpi.com/2673-527X/4/1/6

Airway Stents in Interventional Pulmonology Overall, complications occurred in 33% of cases with stent migration (14%), granulation tissue formation (7%), and mucous plugging (5%) being the most common.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11437588/

A multicenter observational study assessing the safety ... Our study is the first multicenter study that found a good safety profile with a low complication rate after tracheobronchial Bonastent ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0954611123002081

How risky is it to remove an airway stent? Three complications were noted: hemorrhage (n = 1, 2.3%) and stridor (n = 2, 4.6%); one not directly related to the stent removal. Conclusions. Covered metal or ...

8. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202504-1026ED

American Journal of Respiratory and Critical Care Medicine Bronchoscopists commented that the stents were easy to place in almost all instances. Only 27 of the scaffolds required removal, and no injuries were reported ...