Unilateral vs. Bilateral Lung Volume Reduction Surgery

NCT07731958 · tracked via the Priya Life Science Denmark tracker

Sponsor

Copenhagen University Hospital, Rigshospitalet

Phase

Not applicable

Started

2025-03-21

Last updated

2026-07-28

Condition(s) studied

Emphysema, Pulmonary

Investigational drug(s) / intervention(s)

Unilateral LVRSBilateral LVRS

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.

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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).

Primary outcome measure(s)

Lung function — 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.

Trial sites (1)

Facility	City	Region	Status
Rigshospitalet	Copenhagen	Denmark	Recruiting

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

Effect of Large Neutral Amino Acids in Adults With Classical Phenylketonuria Recruiting

Immediate Versus Postponed Single Blastocyst Transfer in mNC-FET Active, not recruiting

The Copenhagen Gender Identity Cohort Recruiting

Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection Recruiting

Precision Medicine in the Depression Treatment Recruiting

Other trials for the same condition

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07731958 on ClinicalTrials.gov ↗ ← All trials in Denmark