COPDTENCT00650559
Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema
A study testing Chest wall enlargement in people with COPD and Emphysema, run by KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- What is being tested?
- Chest wall enlargement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Resting CO2 < 50 mmHg
- diffusion capacity > 20% predicted
- age < 70 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Chest wall enlargement
- Keywords
- COPD, Emphysema, thorax enlargement, LVRS
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest wall enlargementProcedure or surgery
Also called PEEK cages
Widening sternotomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Experimental surgical intervention. Receives: Procedure: Chest wall enlargement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of FEV1
Measured: 1 year
Secondary outcomes (1)
Improvement of exercise capacity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJun 2004
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: post-surgical complications in the last 2 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Marc Decramer, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650559
- Sponsor's protocol ID
- TE-001
- Other IDs
- No grants or contracts
- Acronym
- TE
- Status last verified
- Mar 2008
- First submitted
- 28 Mar 2008
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Wall Enlargement by Widening Sternotomy in Patients With Severe Emphysema: a Feasibility Trial.
- ClinicalTrials.gov ID
- NCT00650559
- Acronym / sponsor ID
- TE / TE-001
- Keywords
- COPD, Emphysema, thorax enlargement, LVRS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: post-surgical complications in the last 2 patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Chest wall enlargementExperimental surgical intervention. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- patients with end-stage emphysema and
- Disabling dyspnea
- GOLD III or IV
- Residual volume > 200% predicted
- Total Lung capacity > 120% predicted
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest wall enlargementAlso: PEEK cagesWidening sternotomy | Procedure or surgery | 1 |
Primary outcome
Improvement of FEV1
Time frame: 1 year
1 secondary outcome
Improvement of exercise capacity
Time frame: 1 year
Results and safety
The study was stopped early (reason given: post-surgical complications in the last 2 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Decramer, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest wall enlargement in people with COPD and Emphysema, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: post-surgical complications in the last 2 patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of FEV1 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2008.