Emphysema, PulmonaryNCT07731958
Unilateral vs. Bilateral Lung Volume Reduction Surgery
A study testing Unilateral LVRS and Bilateral LVRS in people with Emphysema, Pulmonary, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Emphysema, Pulmonary
- What is being tested?
- Unilateral LVRS and Bilateral LVRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Mar 2025to Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2300
Alberte Lund, MD, +4535458016, alberte.lund@regionh.dk
René Horsleben Petersen, MD, Professor, +4535450525, rene.horsleben.petersen@regionh.dk
About this study
Official title: Unilateral Versus Bilateral Lung Volume Reduction Surgery for Patients With Severe COPD
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).
Read the 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.
- Conditions
- Emphysema, Pulmonary
- Being tested
- Unilateral LVRS, Bilateral LVRS
- Keywords
- Thoracic surgery, VATS, LVRS, Lung volume reduction surgery, Lung function, Mortality, Dyspnea
- Medical subject headings
- Pulmonary Emphysema, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral LVRSProcedure or surgery
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.
Bilateral LVRSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral LVRS | Experimental | Not described Receives: Procedure: Bilateral LVRS |
| Unilateral LVRS | Active comparator | Not described Receives: Procedure: Unilateral LVRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months and 12 months after surgery
Secondary outcomes (1)
Mortality
Thirty day mortality rate
Measured: Thirty days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start21 Mar 2025
- Primary completionJul 2031 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emphysema, PulmonaryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Alberte Lund, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731958
- Sponsor's protocol ID
- H-23033301
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Versus Bilateral Lung Volume Reduction Surgery for Patients With Severe COPD
- ClinicalTrials.gov ID
- NCT07731958
- Acronym / sponsor ID
- H-23033301
- Conditions
- Emphysema, Pulmonary
- Keywords
- Thoracic surgery, VATS, LVRS, Lung volume reduction surgery, Lung function, Mortality, Dyspnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bilateral LVRS | Experimental | Procedure: Bilateral LVRS |
| Unilateral LVRS | Active comparator | Procedure: Unilateral LVRS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Suitable target areas in both lungs
- Age ≥ 18 years.
- Speaks and understands Danish or English
- Informed consent obtained
- Usual inclusion criteria in LVRS:
Key exclusion criteria (10 listed)
- Dependent on wheelchair
- Living in nursery home
- Dependent on walker device
- Psychiatric disorder (anxiety, depression, schizophrenia)
- Simultaneous lung cancer surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral LVRSBoth 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. | Procedure or surgery | Unilateral LVRS |
| Bilateral LVRSBoth 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. | Procedure or surgery | Bilateral LVRS |
Primary outcome
Lung function
Time frame: 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.
1 secondary outcome
Mortality
Time frame: Thirty days from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral LVRS and Bilateral LVRS in people with Emphysema, Pulmonary, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberte Lund, MD (+4535458016, alberte.lund@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: 3 months and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.