Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema

NCT ID: NCT00650559

Last Updated: 2008-04-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2006-12-31

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.

Conditions

COPD; Emphysema

Keywords

COPD; Emphysema; thorax enlargement; LVRS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Experimental surgical intervention.

Group Type: EXPERIMENTAL

Chest wall enlargement

Intervention Type: PROCEDURE

Widening sternotomy

Interventions

Chest wall enlargement

Widening sternotomy

Intervention Type: PROCEDURE

Other Intervention Names

PEEK cages

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Leuven

Principal Investigators

Marc Decramer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

University hospital Leuven

Leuven, Flanders, Belgium

Countries

Belgium

Other Identifiers

No grants or contracts

Identifier Type: -

Identifier Source: secondary_id

TE-001

Identifier Type: -

Identifier Source: org_study_id