Unilateral vs bilateral lung volume reduction surgery for emphysema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares unilateral LVRS to bilateral LVRS in adults with moderate to severe COPD and severe emphysema. It uses modern surgical techniques and enhanced recovery practices to evaluate outcomes related to lung function, exercise capacity, and recovery. The study aims to provide up-to-date, randomized-like evidence to determine which approach yields greater benefit with acceptable risk. Eligible participants must meet standard LVRS criteria and be suitable for surgery and rehabilitation, with Danish or English language ability. Primary objectives focus on comparative effectiveness and safety of the two surgical approaches.

Why it matters

Who can join: the full rules

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).

Where it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Study coordinator: Alberte Lund, MD
• Email: alberte.lund@regionh.dk
• Phone: +4535458016

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.