Surgery for emphysema Respiratory Emphysema
Conditions
Interventions
Patients are randomised via sealed randomised envolopes opened on the day of surgery. Patients are then randomised to LVRS with two different adjuncts to staple line:
1. BioGlue®
2. Pericardial buttre
Sponsors
Heart of England NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing LVRS 2. Forced expiratory volume in one second (FEV1) less than 40% 3. FEV1/forced vital capacity (FVC) ratio less than 50% following challenges with beta 2 agonists/ipratropium bromide and a trial of oral corticosteroids 4. Residual volume of greater than 140% 5. Severe emphysema with heterogeneity ("target areas") documented on high resolution computed tomography (CT) scans 6. Less than 75 years of age, but greater than 18 years of age, either sex 7. Clinically stable for 1 month before entry to the study
Exclusion criteria
Exclusion criteria: 1. Patients who do not consent to the trial 2. Patients with known hypersensitivity to albumin, bovine products, or glutaraldehyde 3. Patients who have been treated with an investigational product and have not completed the entire follow-up period for that investigational product 4. Patients who are unwilling or unable to complete all study evaluations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate an increase in the frequency of an air leak free post-operative hospital course for patients receiving BioGlue® as a pneumostatic sealant as compared to patients receiving the pericardial buttressed stapling. Post-operatively, occurrence of air leaks will be assessed on a per patient basis, twice daily. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of re-operation due to air leaks 2. Volume of fluid loss in chest tube drain 3. Time to air leak cessation 4. Incidence of complications/adverse events 5. Early (hospital discharge) mortality and late mortality (through final follow-up) Measured twice daily. | — |
Countries
United Kingdom
Outcome results
None listed