Cryospray Therapy for Benign Airway Stenosis: a Pilot Study (Pilot-CRYOSTASIS)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Degree of re-stenosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to the use of SCT to prevent knowledge of their group assignment from biasing their subjective assessments. Adjudicators in the primary outcome measurements (quantitative CT) will be blinded to group assignment as well.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referral to interventional pulmonology or otorhinolaryngology or thoracic surgery for endoscopic management of suspected benign tracheal stenosis.
- •Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or previous bronchoscopy
- •Able to provide informed consent.
- •Age > 18
排除标准
- •Inability to provide informed consent
- •Pregnancy
- •Known or suspected malignant central airway stenosis
- •Patient has already been enrolled in this study.
- •Study subject has any disease or condition that interferes with safe completion of the study including:
- •Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
- •Pneumothorax in the previous 12 months
- •Severe COPD (defined as a FEV1/FVC < 70% and FEV1 <30% predicted) and/or severe persistent asthma.
- •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.
- •Compromised tissue where significant ulceration or mucosal break is evident in the ablation area or adjacent organs.
- •Significantly reduced tissue strength caused by prior procedure or pre-existing condition (e.g. PEG tube)
- •Significantly reduced elasticity of the ablation area (e.g. Marfan's Syndrome)
- •Prior complications with SCT (Spray cryotherapy)
- •Contraindication to rigid bronchoscopy
- •Significant tracheomalacia or alterations in cartilage integrity on CT (Computed Tomography) that would require stent placement or surgical referral.
- •Greater than 1 BCAS intervention, excluding cricotracheal (tracheal surgery) resection, within 6 months before enrollment.
- •Anatomical flow resistance (gas evacuation) where any procedure or anatomy proximal to the ablation site has significantly reduced or restricted the flow area of the lumen creating restriction where gas created from liquid nitrogen cannot adequately vent.
结局指标
主要结局
Degree of re-stenosis
时间窗: 6 months
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.
次要结局
- Change in Peak Expiratory Flow (PEF)(Continous for 6 months)
- Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ)(2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark,)
- Incidence of complications between groups(Continous for 6 months)