Unilateral vs. Bilateral Lung Volume Reduction Surgery

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).

Study Overview

• Status: Recruiting
• Conditions: Emphysema, Pulmonary
• Intervention / Treatment: Procedure: Bilateral LVRS; Procedure: Unilateral 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 Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberte Lund, MD; Phone Number: +4535458016; Email: alberte.lund@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2300
    • Recruiting
    • Rigshospitalet
    • Contact: Alberte Lund, MD; Phone Number: +4535458016; Email: alberte.lund@regionh.dk
    • Contact: René Horsleben Petersen, MD, Professor; Phone Number: +4535450525; Email: rene.horsleben.petersen@regionh.dk
    • Sub-Investigator: René Horsleben Petersen, MD, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral LVRS	Procedure: Bilateral LVRS; 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.
Active Comparator: Unilateral LVRS	Procedure: Unilateral LVRS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Thirty day mortality rate	Thirty days from surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea	MRC-score and CAT-score	3 and 12 months after surgery
Physical activity	Six minute walking test (meters)	3 and 12 months after surgery
Postoperative complications	Rate of procedure related complications including pneumonia and empyema.	During admission
Chest drain	Number of days with chest drain	During admittance
Length of stay	Length of stay	During admittance
Reoperation rate	Reoperation rate due to airleak, bleeding or other causes	During admittance
Admittance to ICU	Admittance to ICU.	During admittance
Quality of life score	Saint George Respiratory Questionaire	3 and 12 months after surgery
Physical activity level	Activity wristband measuring physical activity out of hospital.	3 and 12 months after surgery

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2025
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Mortality; Lung function; VATS; Dyspnea; LVRS; Thoracic surgery; Lung volume reduction surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Signs and Symptoms, Respiratory; Pulmonary Disease, Chronic Obstructive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pulmonary Emphysema; Dyspnea
• Other Study ID Numbers: H-23033301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No