Unilateral vs. Bilateral Lung Volume Reduction Surgery (NCT07731958) | Clinical Trial Compass
RecruitingNot Applicable
Unilateral vs. Bilateral Lung Volume Reduction Surgery
Denmark146 participantsStarted 2025-03-21
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cardiothoraci…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.