Cryospray Therapy for Benign Airway Stenosis
Trial Summary
What is the purpose of this trial?
Benign central airway stenosis (BCAS) is an important cause of both pulmonary morbidity and mortality. Notable causes include post-intubation stenosis, collagen vascular diseases, airway trauma, infectious and idiopathic subglottic stenosis (iSGS). Surgery is the preferred definite option; however, the first therapeutic attempt is usually endoscopic to temporarily restore airway patency and symptomatic improvement. Several endoscopic modalities exist for treatment. Most commonly, thermal or laser therapy to make radial incisions into the stenotic lesion, followed by balloon dilation to increase the area of patency. Clinicians may also inject steroids or antineoplastic agents such as mitomycin C. All of these methods have benefits and associated risks. Symptomatic stenosis frequently reoccurs with these methods. For example, the investigators have been doing 3-4 ballon dilations procedures a week at our institution. Spray cryotherapy (SCT) is a novel FDA-cleared technique that allows for liquid nitrogen to be delivered through the working channel of a bronchoscope. Few retrospective studies exist without more robust clinical trial data to reduce the risk of bias and support its widespread use. The investigators postulate that SCT and standard of care techniques will improve airway patency volume at six months than the standard of care techniques alone. Some of the proposed advantages include improved wound healing which may translate to less scar tissue and thus improvements in airway patency for a longer duration of time.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for benign airway stenosis?
Spray cryotherapy (SCT) has shown promise in managing benign airway strictures by potentially reducing fibrosis (scar tissue formation) and the need for further interventions, according to initial results. Although evidence is limited, SCT has been used effectively to relieve symptoms in airway obstructions, suggesting it may help in similar conditions.12345
Is spray cryotherapy safe for treating airway conditions?
Spray cryotherapy (SCT) has been used to treat airway conditions, but there have been reports of significant hemodynamic complications (issues with blood flow and pressure) during its use. While SCT is considered a potential therapy for maintaining airway patency, its safety, particularly regarding the integrity of airway stents, has not been fully established.12567
How is spray cryotherapy different from other treatments for benign airway stenosis?
Spray cryotherapy (SCT) is unique because it uses ultra-low temperatures to treat airway stenosis without direct contact, potentially reducing complications like granulation tissue and fibrosis that are common with other endoscopic therapies. This non-invasive approach may also allow stents to remain in place during treatment, unlike thermal ablation, which carries risks of airway fire and damage to stents.23567
Research Team
Fabien Maldonado, MD
Principal Investigator
Vanderbilt University Medical Center
Eligibility Criteria
This trial is for adults over 18 with significant tracheal stenosis, which means their airway passage is narrowed by at least half. They should be referred for endoscopic treatment of suspected benign tracheal stenosis and able to consent. It's not for those with malignant stenosis, recent multiple treatments, oxygen needs above a certain level, severe lung conditions like COPD or asthma, unstable blood pressure or heart rate, cartilage issues needing surgery or a history of complications from cryotherapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo bronchoscopic balloon dilation with radial cuts and truFreeze spray cryotherapy
Initial Follow-up
Participants have a thin cut CT scan and pulmonary function testing within 6 weeks post-procedure
Extended Follow-up
Participants are monitored for changes in airway patency and quality of life, with repeat CT scan and questionnaires at 6 months
Treatment Details
Interventions
- Ballon Dilation
- Radial Incision
- Spray cryotherapy
Spray cryotherapy is already approved in United States for the following indications:
- Benign central airway stenosis
- Post-intubation stenosis
- Collagen vascular diseases
- Airway trauma
- Infectious subglottic stenosis
- Idiopathic subglottic stenosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Virginia Commonwealth University
Collaborator
University of Mississippi Medical Center
Collaborator