DIVision of the Interlobar Fissure in Patients Who Do Not Respond to Endobronchial Lung Volume Reduction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Number of patients recruited
研究概览
简要总结
Surgical division of fissure is hypothesized to be safe and feasible. However, there is no preparatory study to test this hypothesis. It is logically expected that morbidity from the procedure could be less than standard LVRS and in preparation to a side-to-side trial of fissure division versus standard LVRS, a safety and feasibility study is required to test this hypothesis and inform future trial design.
详细描述
• Rationale
Lung volume reduction surgery (LVRS) and Endobronchial lung volume reduction (EBLVR) are both established treatment options for selected patients with symptomatic emphysema. In a randomized trial EBLVR was found to be non-inferior to LVRS in efficacy but uses fewer hospital resources.
Fissure completeness is however necessary for EBLVR to work and this is initially assessed on CT imaging and quantified by a software-based analysis called StratX. If anatomical completeness is less than 80% on StratX, EBLVR cannot be pursued, whereas if fissures are more than 80% complete, further functional assessment with a bronchoscopy and a balloon test called Chartis is required. The presence of a functionally incomplete fissure is called collateral ventilation and precludes EBLVR. If collateral ventilation is absent, EBVs can then be inserted in the target lung lobe.
The intended outcome of the procedure is the achievement of target lobar atelectasis (TLA), leading to reduced hyperinflation and improvement of the dyspnea.
When TLA is not achieved, current best practice is to obtain a CT to check for signs of EBV displacement or paravalvular leak. A further post-procedure StratX is also obtained to identify which valves or airways are affected. A revisional bronchoscopy is then performed to replace/reinsert valves or exclude other causes of malfunctioning such as mucus plugs or granulation tissue formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < or equal 75 years
- •Stable COPD with less than or equal to 10mg prednisolone daily
- •Nonsmoking for 3 months prior to screening and willing to not smoke during the study duration
- •Willing and able to complete protocol required study follow-up assessments and procedures
- •Fit for thoracoscopy under general anaesthesia (surgical and anaesthetic assessment)
- •Recent (< 18 months) endobronchial lung volume reduction (EBLVR) and lack of response defined by:
- •Persistent symptomatic dyspnoea (mMRC >2) which in the patient's view is no better than baseline
- •Absence of target lobar collapse with any residual aeration apparent on imaging
- •Persistence of (6a) and (6b) following post procedure StratX CT analysis and revisional bronchoscopy.
排除标准
- •Fissure completeness <90% on pre EBLVR StratX (i.e less than 10% of fissure to be divided)
- •Chartis positive for collateral ventilation or not performed/not satisfactory at initial EBLVR
- •Quantitative perfusion of target lobe >25% of total on SPECT assessment.
- •Previous lung surgery or pleurodesis on the target side for LVR.
- •Clinically significant bronchiectasis -greater than 4 tablespoons mucus per day.
- •More than 3 COPD exacerbation episodes in the last year.
- •Evidence of hypercapnia (pCO2 >7KPa) - ABG to be performed on admission for index procedure
- •Clear evidence of pulmonary hypertension (systolic pulmonary arterial pressure >45mmHg) or evidence or right ventricular dysfunction as determined by a recent echocardiogram (<12mo)
- •Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (<12mo)
- •Myocardial infarction within 6 months of screening.
- •Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.
结局指标
主要结局
Number of patients recruited
时间窗: 18 months
At least 15 patients recruited into the trial over 18 months
Number of patients where surgical division of inter-lobar fissure can be successfully completed
时间窗: Through study completion (18 months)
Division of inter-lobar fissure can be completed in 90% of the patients enrolled
Number of patients who experience serious adverse events as a result of the intervention
时间窗: Through study completion (18 months)
Number of patients who experience serious adverse events as a result of the intervention
次要结局
- Target lobar collapse(Through study completion (18 months))
- Costs(Through study completion (18 months))
研究者
Rocco Bilancia
Consultant Thoracic Surgeon
Golden Jubilee National Hospital