NCT07731958 Unilateral vs. Bilateral Lung Volume Reduction Surgery
| NCT ID | NCT07731958 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Emphysema, Pulmonary |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2031-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 146 participants in total. It began in 2025-03-21 with a primary completion date of 2031-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07731958 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Emphysema, Pulmonary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07731958 currently recruiting?
Yes, NCT07731958 is actively recruiting participants. Contact the research team at alberte.lund@regionh.dk for enrollment information.
Where is the NCT07731958 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT07731958 clinical trial?
NCT07731958 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 146 participants.