Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft
18 Years
N/A
Both
Lung Cancer, Tracheal Neoplasm, Benign Tracheal Stenosis
Trial Information
Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft
Surgery remains the best option for curative treatment of early stages Non-Small Cell Lung
Cancer (NSCLC). Peripheral tumors are usually resected using lobectomy with a low 90-day
morbidity and mortality rate (2%). Central NSCLC often require a pneumonectomy with a high
90-day morbidity and mortality rate (up to 24%), especially when some factors are present:
age > 70 years, right side, neoadjuvant chemoradiotherapy. On the other hand, bronchoplastic
lobectomies have been proposed in order to avoid pneumonectomy. However, more than fifty
years after their first description, bronchoplastic lobectomies remain uncommon (<1% of all
pulmonary resection). This could be explained by some technical difficulties showing the
potential interest of a bronchial substitute. In a 10-year research phase on a sheep model
(n=108), we demonstrated that aortic grafts could be valuable substitutes for
tracheobronchial replacement. We observed a progressive transformation of the aortic tissue
into airway tissue comprising epithelium and regenerated cartilage. The technique was
extended to clinical tracheal replacement by us and others with encouraging results. We
proposed to evaluate the feasibility of the use of a stent-supported cryopreserved aortic
allograft as a bronchial substitute to prevent pneumonectomy and its associated high
mortality rate in NSCLC surgery. Primary outcome will be the 90-day mortality. Secondary
outcomes will be the postoperative complications, the 90-day morbidity. This prospective
open study will include 20 to 30 patients according to eligibility criteria (see below). The
operation will consist of the curative resection of the NSCLC followed by the replacement of
a bronchial segment using a cryopreserved allograft in order to re-implant a functional
pulmonary lobe. A stent will be placed in the graft to prevent airway collapse.
-Current study (TRACHEO BRONC-ART) The BRONC-ART study was extended to major (malignant or
benign) lesions of the trachea requiring airway transplantation. For these patients,
resection followed by direct end to end anastomosis is not possible or at high risk.
Inclusion Criteria:
- patient age ≥18 years and patient capable of giving consent to the carrying out of a
medical research procedure
- patient with proximal Lung Cancer (LC) requiring surgical resection (carinal
resection, pneumonectomy, bronchoplastic lobectomy) after neoadjuvant chemotherapy or
not and with adequate preoperative lung function tests
- or patient with proximal LC requiring a pneumonectomy without adequate preoperative
lung function tests
- patients with extended lesions malignant or benign of the trachea without bronchic
lesion and who are in therapeutic impasse.
- or patient older than 70 years with proximal LC requiring a pneumonectomy
- decision made by a multidisciplinary team
- patient information and consent
Exclusion Criteria:
- patient age < 18 years or patient not capable of giving consent to the carrying out
of a medical research procedure
- patient with proximal or peripheral LC requiring a simple lobectomy
- patient with unresectable LC because of major local involvement, N3 and/or M1
status(with the exception of a unique resectable brain metastasis)
- patient with tracheal lesion that can be isolated from a simple resection anastomosis
tracheal
- iodine allergy
- preoperative evaluation not allowing a simple lobectomy
- patient not affiliated to the French Social Security System
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
90-day mortality
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Emmanuel MARTINOD, Pr, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
P091203
NCT ID:
NCT01331863
Start Date:
May 2011
Completion Date:
December 2013
Related Keywords:
- Lung Cancer
- Tracheal Neoplasm
- Benign Tracheal Stenosis
- Bronchial disease
- Lung cancer surgery
- Aorta/aortic Allograft
- homograft
- Tracheal disease
- Benign
- Malignant
- Neoplasms
- Lung Neoplasms
- Tracheal Neoplasms
- Tracheal Stenosis
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