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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00650559
Recruitment Status : Terminated (post-surgical complications in the last 2 patients)
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
Information provided by:
Katholieke Universiteit Leuven

March 28, 2008
April 1, 2008
April 1, 2008
June 2004
December 2006   (Final data collection date for primary outcome measure)
Improvement of FEV1 [ Time Frame: 1 year ]
Same as current
No Changes Posted
Improvement of exercise capacity [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema
Chest Wall Enlargement by Widening Sternotomy in Patients With Severe Emphysema: a Feasibility Trial.
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.
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • COPD
  • Emphysema
Procedure: Chest wall enlargement
Widening sternotomy
Other Name: PEEK cages
Experimental: 1
Experimental surgical intervention.
Intervention: Procedure: Chest wall enlargement
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2006
December 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
No grants or contracts
Not Provided
Not Provided
Marc Decramer, University Hospital Leuven
Katholieke Universiteit Leuven
Not Provided
Principal Investigator: Marc Decramer, MD, PhD Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP