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

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.

Study Overview

• Status: Terminated
• Conditions: Emphysema; COPD
• Intervention / Treatment: Procedure: Chest wall enlargement

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Flanders
    • Leuven, Flanders, Belgium, 3000
      • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Experimental surgical intervention.	Procedure: Chest wall enlargement; Widening sternotomy; Other Names: PEEK cages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of FEV1	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement of exercise capacity	1 year

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Marc Decramer, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Estimate): April 1, 2008
• Last Update Submitted That Met QC Criteria: March 28, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: COPD; Emphysema; LVRS; thorax enlargement
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: TE-001; No grants or contracts