Emphysema, Pulmonary
Conditions
Keywords
Thoracic surgery, VATS, LVRS, Lung volume reduction surgery, Lung function, Mortality, Dyspnea
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREUnilateral LVRS
Both unilateral and bilateral LVRS are done with a standardized 3 port VATS access. Lower ligament is freed, no graspers on the parenchyma and stapling of the selected areas with a Signia™ powered stapler with Tri-Staple™ technology (Medtronic). The reloads will not be butressed and it will be vascular or parenchymal reloads. Two drains will be placed on the operated side and the same pain management will be applied including perioperative blocs and a pain catheter. The unilateral procedures will be performed with the patient in a side position. Postoperatively the drains will be removed when there is no sign of air leakage on the digital chest drain system. Chest x-ray will be performed to secure a fully inflated lung before discharge.
PROCEDUREBilateral LVRS
Both unilateral and bilateral LVRS are done with a standardized 3 port VATS access. Lower ligament is freed, no graspers on the parenchyma and stapling of the selected areas with a Signia™ powered stapler with Tri-Staple™ technology (Medtronic). The reloads will not be butressed and it will be vascular or parenchymal reloads. Two drains will be placed on the operated side and the same pain management will be applied including perioperative blocs and a pain catheter. In the bilateral procedures the paBent will be positioned on the back and the side to be operated on liked by rotating the table. The surgeon is free to decide which side to deal with first. Postoperatively the drains will be removed when there is no sign of air leakage on the digital chest drain system. Chest x-ray will be performed to secure a fully inflated lung before discharge.
Sponsors
Rigshospitalet, Denmark
Medtronic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Type of Study: Single-center, open-label, 1:1 randomized controlled trial. Sample Size: The study aims to enroll 146 patients in total, with 73 patients randomly assigned to each group. Key Inclusion Criteria: Patients under 75 years old with moderate-to-severe COPD, suitable surgical targets in both lungs, severe lung hyperinflation, and at least six months of smoking abstinence. Key Exclusion Criteria: Dependence on a wheelchair or walker, living in a nursing home, active psychiatric disorders, or a history of previous cardiothoracic surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung function | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Thirty days from surgery | Thirty day mortality rate |
Countries
Denmark
Contacts
CONTACTAlberte Lund, MD
Outcome results
None listed