An interventional study of Unilateral LVRS and Bilateral LVRS in Emphysema, Pulmonary, sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
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).
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.
64 studies on the registry are indexed under Pulmonary Emphysema; 7 are open to participants now.
This study's planned enrollment of 146 is above the median of 33 across 49 interventional studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Moderate to severe with MRC score > 2 \< 75 years old 17 \< > 30 > 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 on CT scan Absence of significant comorbidity including severe cardiovascular disease 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Bilateral LVRS
Procedure: Unilateral 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.
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.
Lung function
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.
Time frame: 3 months and 12 months after surgery
Mortality
Thirty day mortality rate
Time frame: Thirty days from surgery
Dyspnea
MRC-score and CAT-score
Time frame: 3 and 12 months after surgery
Physical activity
Six minute walking test (meters)
Time frame: 3 and 12 months after surgery
Postoperative complications
Rate of procedure related complications including pneumonia and empyema.
Time frame: During admission
Chest drain
Number of days with chest drain
Time frame: During admittance
Length of stay
Length of stay
Time frame: During admittance
Reoperation rate
Reoperation rate due to airleak, bleeding or other causes
Time frame: During admittance
Admittance to ICU
Admittance to ICU.
Time frame: During admittance
Quality of life score
Saint George Respiratory Questionaire
Time frame: 3 and 12 months after surgery
Physical activity level
Activity wristband measuring physical activity out of hospital.
Time frame: 3 and 12 months after surgery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for Jul 2031, 76 months after the start.
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