Unilateral vs. Bilateral Lung Volume Reduction Surgery

NCT07731958 | Recruiting

• 1 other identifier: H-23033301
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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).

Conditions

Emphysema, Pulmonary

Keywords

Thoracic surgery; VATS; LVRS; Lung volume reduction surgery; Lung function; Mortality; Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mortality

  Thirty days from surgery

Other Outcomes (9)

• Dyspnea

  3 and 12 months after surgery

• Physical activity

  3 and 12 months after surgery

• Postoperative complications

  During admission

Study Arms (2)

Bilateral LVRS

EXPERIMENTAL

Procedure: Bilateral LVRS

Unilateral LVRS

ACTIVE COMPARATOR

Procedure: Unilateral LVRS

Interventions

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.

Unilateral LVRS

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.

Bilateral LVRS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suitable target areas in both lungs
• Age ≥ 18 years.
• Speaks and understands Danish or English
• Informed consent obtained
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Medtronic: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2300, Denmark

RECRUITING

MeSH Terms

Conditions

Pulmonary Emphysema; Dyspnea

Condition Hierarchy (Ancestors)

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Alberte Lund, MD

CONTACT

+4535458016; alberte.lund@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD and Phd student

Model Details: Type of Study: Single-center, open-label, 1:1 randomized controlled trial. Sample Size: The study aims to enroll 146 patients in total, with 73 patients randomly assigned to each group. Key Inclusion Criteria: Patients under 75 years old with moderate-to-severe COPD, suitable surgical targets in both lungs, severe lung hyperinflation, and at least six months of smoking abstinence. Key Exclusion Criteria: Dependence on a wheelchair or walker, living in a nursing home, active psychiatric disorders, or a history of previous cardiothoracic surgery.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 28, 2026
• Study Start: March 21, 2025
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2032
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)