TRACHBRONCAR: Airway and/or Pulmonary Vessels Transplantation

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01331863

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

First study (BRONC-ART) The purpose of this prospective study is to evaluate the 90-day morbidity and mortality rates of bronchial transplantation using cryopreserved aortic allograft in proximal lung cancer surgery. The investigators hypothesize that this stage 1-2 surgical innovation could be safe and effective in order to reduce the 90-day morbidity and mortality rates compared to those observed with pneumonectomy, especially when some factors are present: age > 70 years, right side, neoadjuvant chemoradiotherapy.
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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Tracheal Neoplasm Tracheal Stenosis	Procedure: Airway and/or pulmonary Vessels Transplantation	Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft

Actual Study Start Date :

May 31, 2011

Actual Primary Completion Date :

Aug 31, 2018

Actual Study Completion Date :

Nov 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single arm surgery Airway and/or pulmonary Vessels Transplantation	Procedure: Airway and/or pulmonary Vessels Transplantation Use of a stent-supported aortic allograft to prevent pneumonectomy in lung cancer SURGERY

Arm

Intervention/Treatment

Experimental: single arm surgery

Airway and/or pulmonary Vessels Transplantation

Procedure: Airway and/or pulmonary Vessels Transplantation

Use of a stent-supported aortic allograft to prevent pneumonectomy in lung cancer SURGERY

Outcome Measures

Primary Outcome Measures

90-day mortality [3 months]

Secondary Outcome Measures

90-day morbidity [90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 bronchitic 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