Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema

COPD Clinical Trial

— TE  

Official title:

Chest Wall Enlargement by Widening Sternotomy in Patients With Severe Emphysema: a Feasibility Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00650559
• Other study ID #: TE-001
• Secondary ID: No grants or con
• Status: Terminated
• Phase: N/A
• First received: March 28, 2008
• Last updated: March 28, 2008
• Start date: June 2004
• Est. completion date: December 2006

Study information

• Verified date: March 2008
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Emphysema
• Pulmonary Emphysema

Intervention

Procedure:
• Chest wall enlargement
Widening sternotomy

Locations

Country	Name	City	State
Belgium	University hospital Leuven	Leuven	Flanders

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of FEV1		1 year	No
Secondary	Improvement of exercise capacity		1 year	No