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Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)

Sponsored by Vanderbilt University Medical Center

About this trial

Last updated 2 years ago

Study ID

211177

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

1. Referral to interventional pulmonology or ENT for endoscopic management of suspected benign tracheal stenosis.

2. Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or symptomatology warranting evaluation.

3. Able to provide informed consent

4. Age > 18

No

Exclusion Criteria

1. Inability to provide informed consent.

2. Pregnancy

3. Known or suspected malignant central airway stenosis

4. Patient has already been enrolled in this study.

5. Study subject has any disease or condition that interferes with safe completion of the study including:

1. Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
2. Recent pneumothorax in the previous 12 months
3. Severe COPD (defined as a FEV1/FVC < 70% and FEV1 < 30% predicted) and/or severe persistent asthma.
4. Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the attending physicians.
5. Prior complications with SCT

6. Contraindication to rigid bronchoscopy

7. Significant tracheomalacia or alterations in cartilage integrity that would require stent placement or surgical referral as assessed by CT imaging.

8. Greater then 1 BCAS intervention within 6 months before enrollment

Locations

Location

Status

Recruiting