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Trial record 5 of 13 for:    Open Studies | "Tracheal Diseases"

Airway and/or Pulmonary Vessels Transplantation (TRACHBRONC-ART)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01331863
First received: April 7, 2011
Last updated: September 16, 2013
Last verified: September 2013
  Purpose
  • 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 Intervention Phase
Lung Cancer
Tracheal Neoplasm
Benign Tracheal Stenosis
Procedure: Airway and/or pulmonary Vessels Transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 90-day mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 90-day morbidity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Airway and/or pulmonary Vessels Transplantation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331863

Locations
France
Assistance Publique Hôpitaux de Paris, Hôpital Avicenne, CHU Paris-Seine-Saint-Denis Recruiting
Bobigny, Seine-Saint-Denis, France, 93000
Contact: Emmanuel MARTINOD, MD, PhD    33(0)148955231    emmanuel.martinod@avc.aphp.fr   
Principal Investigator: Emmanuel MARTINOD, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Emmanuel MARTINOD, Pr, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01331863     History of Changes
Other Study ID Numbers: P091203
Study First Received: April 7, 2011
Last Updated: September 16, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Bronchial disease
Lung cancer surgery
Aorta/aortic Allograft
homograft
Tracheal disease
Benign
Malignant

Additional relevant MeSH terms:
Tracheal Diseases
Lung Neoplasms
Tracheal Neoplasms
Tracheal Stenosis
Head and Neck Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014