Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema

Not Applicable

Terminated

• Conditions: COPD; Emphysema
• Interventions: Procedure: Chest wall enlargement

• Registration Number: NCT00650559
• Lead Sponsor: KU Leuven

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 Timeline

• Study Start: 2004-06
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-03
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-28
• Last Update Submitted: 2008-03-28
• Study First Posted: 2008-04-01
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Chest wall enlargement	Experimental surgical intervention.

Primary Outcome Measures

Name	Time	Method
Improvement of FEV1	1 year

Secondary Outcome Measures

Name	Time	Method
Improvement of exercise capacity	1 year

Trial Locations

Locations (1)

University hospital Leuven; 🇧🇪 Leuven, Flanders, Belgium