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Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema (TE)

This study has been terminated.
(post-surgical complications in the last 2 patients)
Sponsor:
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00650559
First received: March 28, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention
COPD
Emphysema
 Procedure: Chest wall enlargement

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chest Wall Enlargement by Widening Sternotomy in Patients With Severe Emphysema: a Feasibility Trial.

Resource links provided by NLM:

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Improvement of FEV1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of exercise capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: June 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Experimental surgical intervention.
 Procedure: Chest wall enlargement
Widening sternotomy
Other Name: PEEK cages

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650559

Locations
Belgium
University hospital Leuven
Leuven, Flanders, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Marc Decramer, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Marc Decramer, University Hospital Leuven
ClinicalTrials.gov Identifier: NCT00650559     History of Changes
Other Study ID Numbers: TE-001, No grants or contracts
Study First Received: March 28, 2008
Last Updated: March 28, 2008
Health Authority: Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:
COPD
Emphysema
thorax enlargement
LVRS

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pulmonary Disease, Chronic Obstructive
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on May 19, 2013