This is a clinical evaluation to assess the effectiveness of cryospray therapy used in addition to current standard of care endoscopic therapies in preventing short term recurrent airway stenosis with a multicentric outcome evaluation. The investigators hypothesize that the addition of SCT to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence at 6 months as estimated by quantitative radiologic assessment of the stenotic volume.
Spray cryo treatment of tracheal stenosis has the potential for long-lasting endoscopic management of BCAS and is used as part of routine clinical care by many physicians, but there is a relative paucity of peer-reviewed data, and no randomized controlled trial has been performed. Thus, the study could potentially show that the use of spray cryo therapy could allow patients to undergo fewer procedures to treat this condition, or lengthen the amount of time required in between these procedures, or play a role in the resolution of this condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
A novel FDA cleared technique that allows for liquid nitrogen (LN2) to be delivered in a metered fashion via a catheter through a flexible bronchoscope.
An endoscopic balloon that is inflated with water to pressures between 45 and 131 psi (3-9 atm) using a syringe and pressure manometer.
Carbon dioxide (CO2) laser or Monopolar electrocautery knife
Virgnia Commonwealth University
Richmond, Virginia, United States
RECRUITINGDegree of re-stenosis
The degree of re-stenosis at 6 months expressed as the percentage of airway lumen volume within the stenotic segment at 6 months compared to personal best patency volume on CT scan performed within five weeks of the study intervention.
Time frame: 6 months
Change in Peak Expiratory Flow (PEF)
Evidence supports the use of PEF as a simple, efficient, and accessible way of monitoring progression of tracheal stenosis. PEF has previously been captured in clinical encounters as component of the decision-making algorithm for surgical intervention in tracheal stenosis patients. Mobile Device Software 'App' can robustly capture longitudinal patient reported outcome measures. A previously developed mobile device software 'Airflo' for tracking patient-generated health data and has proven the ability to successfully implement this software.
Time frame: Continous for 6 months
Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ)
The CCQ has been used as a validated quality of life measure in laryngotracheal stenosis. The investigators will send surveys out to patients at set time intervals to assess symptom improvement pre- and post-intervention. The questions are divided into three areas or domains. Symptoms 1, 2, 5, 6; Functional state 7, 8, 9, 10; Mental state 3 and 4. All items are equally weighted by adding score of ten items and dividing by the number ten. The score varies between 0 (very good health status) to 6 (extremely poor health status).
Time frame: 2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark,
Incidence of complications between groups
Incidence of complications (hypoxemia, bleeding, pneumothorax rate, barotrauma).
Time frame: Continous for 6 months
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