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NCT Number: NCT07731958

Unilateral vs. Bilateral Lung Volume Reduction Surgery

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).

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Unilateral LVRS

Procedure

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 LVRS

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mortality

    Time frame: Thirty days from surgery

    Thirty day mortality rate

Other outcomes

  1. Dyspnea

    Time frame: 3 and 12 months after surgery

    MRC-score and CAT-score

  2. Physical activity

    Time frame: 3 and 12 months after surgery

    Six minute walking test (meters)

  3. Postoperative complications

    Time frame: During admission

    Rate of procedure related complications including pneumonia and empyema.

  4. Chest drain

    Time frame: During admittance

    Number of days with chest drain

  5. Length of stay

    Time frame: During admittance

    Length of stay

  6. Reoperation rate

    Time frame: During admittance

    Reoperation rate due to airleak, bleeding or other causes

  7. Admittance to ICU

    Time frame: During admittance

    Admittance to ICU.

  8. Quality of life score

    Time frame: 3 and 12 months after surgery

    Saint George Respiratory Questionaire

  9. Physical activity level

    Time frame: 3 and 12 months after surgery

    Activity wristband measuring physical activity out of hospital.

Study contacts

Contact information is provided by the study sponsor or research team.

Alberte Lund, MD

CONTACT

[email protected]

+4535458016

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Medtronic

Registry information

Official study title

Unilateral Versus Bilateral Lung Volume Reduction Surgery for Patients With Severe COPD

Important dates

Study start
2025
Primary completion
2031
Study completion
2032
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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