Unilateral vs. Bilateral Lung Volume Reduction Surgery
Recruiting · NCT07731958 · Interventional (participants receive a specific treatment) · Lead sponsor: Rigshospitalet, Denmark
View the official record on ClinicalTrials.gov →Interventions studied
Bilateral LVRSUnilateral LVRS
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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).
Where it is running
1 location listed.
- Rigshospitalet - Copenhagen, Denmark