Unilateral Versus Bilateral Lung Volume Reduction Surgery for Patients With Severe COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Lung function
研究概览
简要总结
This study compares two surgical approaches for patients with severe Chronic Obstructive Pulmonary Disease (COPD) and severe emphysema: unilateral (operating on one lung) versus bilateral (operating on both lungs) lung volume reduction surgery (LVRS).
详细描述
Lung volume reduction surgery removes damaged lung tissue to help patients breathe better, improve life quality, and increase exercise capacity. Historically, the hospital has performed this surgery unilaterally, while global standards often favor bilateral surgery to maximize lung function benefits.Existing data suggesting bilateral surgery is better is more than 20 years old, lacks randomization, and was gathered before modern surgical advances like keyhole surgery (VATS) and Enhanced Recovery After Surgery (ERAS) protocols. Additionally, bilateral surgery may carry higher risks of postoperative complications, longer hospital stays, and prolonged air leaks. This study aims to provide modern, unbiased evidence to determine which approach is superior.
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
- 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
- •Suitable target areas in both lungs
- •Age ≥ 18 years.
- •Speaks and understands Danish or English
- •Informed consent obtained
- •Usual inclusion criteria in LVRS:
- •Moderate to severe COPD with MRC score > 2 < 75 years old 17 < BMI > 30 FEV1 > 20% and < 45% of predicted RV > 200% of predicted as a sign of relevant hyperinflation DLCO > 20% of predicted The patient should be in ideal medical treatment and have completed rehabilitation A high-resolution CT < 3 months old should follow the referral to MDT Absence of nodules suspicious of malignancy on CT scan Absence of significant comorbidity including severe cardiovascular disease LVEF normal Absence of pulmonary hypertension, TI-gradient < 40 mmHg Absence of chronic or frequent lung infections Smoking abstinence six months prior to surgery Assessed as sufficiently physically fit to undergo surgery and rehabilitation
排除标准
- •Dependent on wheelchair
- •Living in nursery home
- •Dependent on walker device
- •Psychiatric disorder (anxiety, depression, schizophrenia)
- •Simultaneous lung cancer surgery
- •Massive adhesions during surgery assessed by the surgeon indicating problems postoperatively
- •Increased risk of post-operative bleeding assessed perioperatively by the surgeon.
- •Perioperative decision on not doing operation on the other side (medical, surgical or anaesthesiologic problems that favours a fast termination of the surgery, decided by the team in OR).
- •Previous cardiothoracic surgery
- •Increased bleeding risk (e.g., preoperative INR >2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).
结局指标
主要结局
Lung function
时间窗: 3 months and 12 months after surgery
Change in Forced Expiratory Volume in 1 second, or FEV1) is the primary outcome. All parameters in a complete lunge function test will be evaluated including diffusion capacity of the lung for carbon monoxide, residual volume, total lung capacity, RV-to-TLC ratio.
次要结局
- Mortality(Thirty days from surgery)
研究者
Alberte Lund
MD and Phd student
Rigshospitalet, Denmark