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

Primary Purpose

COPD, Emphysema

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Chest wall enlargement
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Emphysema, thorax enlargement, LVRS

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Experimental surgical intervention.

Outcomes

Primary Outcome Measures

Improvement of FEV1

Secondary Outcome Measures

Improvement of exercise capacity

Full Information

First Posted
March 28, 2008
Last Updated
March 28, 2008
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT00650559
Brief Title
Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema
Acronym
TE
Official Title
Chest Wall Enlargement by Widening Sternotomy in Patients With Severe Emphysema: a Feasibility Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
post-surgical complications in the last 2 patients
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Emphysema
Keywords
COPD, Emphysema, thorax enlargement, LVRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Experimental surgical intervention.
Intervention Type
Procedure
Intervention Name(s)
Chest wall enlargement
Other Intervention Name(s)
PEEK cages
Intervention Description
Widening sternotomy
Primary Outcome Measure Information:
Title
Improvement of FEV1
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Improvement of exercise capacity
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Decramer, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Leuven
City
Leuven
State/Province
Flanders
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema

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