Chest Wall Enlargement by Widening Sternotomy in Patients With Severe Emphysema: a Feasibility Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- KU Leuven
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Improvement of FEV1
Study Overview
Brief Summary
There is a growing population of end-stage COPD patients for whom surgical treatments like lung transplantation and lung volume reduction surgery are not possible. In such patients, size mismatch between large emphysematous lungs and a restricted chest wall is a major cause for the reduction of dynamic lung volumes and consequent dyspnea. We hypothesized that enlargement of the thorax would be a potential alternative strategy to volume reduction surgery as it may improve lung mechanics by resizing the chest to the lung and does not further deprive patients from lung tissue which is already scarce.
Detailed Description
Lung volume reduction surgery primarily increases vital capacity by reducing RV more than TLC. As the chest wall is the major TLC limiting factor, an alternative approach that could circumvent size mismatch would be a surgical enlargement of the thorax cavity. Any post-operative increase of TLC would allow greater dynamic operational lung volumes to occur with an equal amount of dead space. Moreover, resizing of the thorax would have a tremendous advantage over resizing of the lung, in that it would not require resection of the lung in patients in whom lung tissue is already scarce. Chest expansion will only be guaranteed if the sternal widening osteotomy will obtain a solid union. Small poly-ether-ether-keton (PEEK) cages were designed to match both sternal halves in a 'press fit' way, which were filled with lyophilised bone and fixed with extra wires as in a classical sternotomy. These bone-filled cages function as a perfect matrix for progressive in-growth of cancellous bone.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with end-stage emphysema and
- •Disabling dyspnea
- •GOLD III or IV
- •Residual volume > 200% predicted
- •Total Lung capacity > 120% predicted
- •RV/TLC > 0.6
- •Resting CO2 < 50 mmHg
- •diffusion capacity > 20% predicted
- •age < 70 years
Exclusion Criteria
- •previous sternotomy
- •contraindication of general anesthesia
- •chronic treatment with corticosteroids
- •any tobacco use within 6 months
- •candidates for lung volume reduction surgery or lung transplantation
Outcomes
Primary Outcomes
Improvement of FEV1
Time Frame: 1 year
Secondary Outcomes
- Improvement of exercise capacity(1 year)