Unilateral vs. Bilateral Lung Volume Reduction Surgery

ConditionEmphysema, Pulmonary

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorRigshospitalet, Denmark

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Suitable target areas in both lungs

Age ≥ 18 years.

Speaks and understands Danish or English

Informed consent obtained

Disqualifiers

Dependent on wheelchair

Living in nursery home

Dependent on walker device

Psychiatric disorder (anxiety, depression, schizophrenia)

Trial design

Design model

Parallel

Treatments tested in this trial

Unilateral LVRS
Procedure/Surgery
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/Surgery
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.

Treatment groups

146 Participants

are divided into 2 treatment groups

Group A: Bilateral LVRSExperimental treatment 1 intervention

Group B: Unilateral LVRSActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

3 months and 12 months after surgery

Secondary outcomes

Mortality

Thirty day mortality rate

Time frame

Thirty days from surgery

Other outcomes

Dyspnea

MRC-score and CAT-score

Time frame

3 and 12 months after surgery

Physical activity

Six minute walking test (meters)

Time frame

3 and 12 months after surgery

Postoperative complications

Rate of procedure related complications including pneumonia and empyema.

Time frame

During admission

Chest drain

Number of days with chest drain

Time frame

During admittance

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov

Apply now