Rigshospitalet
Copenhagen, 2300, Denmark
Location status: Recruiting
Location contact
Alberte Lund, MD
CONTACT
René Horsleben Petersen, MD, Professor
CONTACT
René Horsleben Petersen, MD, professor
SUB_INVESTIGATOR
NCT Number: NCT07731958
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).
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Copenhagen, 2300, Denmark
Location status: Recruiting
Alberte Lund, MD
CONTACT
René Horsleben Petersen, MD, Professor
CONTACT
René Horsleben Petersen, MD, professor
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
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.
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.
Time frame: Thirty days from surgery
Thirty day mortality rate
Time frame: 3 and 12 months after surgery
MRC-score and CAT-score
Time frame: 3 and 12 months after surgery
Six minute walking test (meters)
Time frame: During admission
Rate of procedure related complications including pneumonia and empyema.
Time frame: During admittance
Number of days with chest drain
Time frame: During admittance
Length of stay
Time frame: During admittance
Reoperation rate due to airleak, bleeding or other causes
Time frame: During admittance
Admittance to ICU.
Time frame: 3 and 12 months after surgery
Saint George Respiratory Questionaire
Time frame: 3 and 12 months after surgery
Activity wristband measuring physical activity out of hospital.
Contact information is provided by the study sponsor or research team.
Rigshospitalet, Denmark
Other
Unilateral Versus Bilateral Lung Volume Reduction Surgery for Patients With Severe COPD
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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