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Airway and/or Pulmonary Vessels Transplantation (TRACHBRONCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01331863
Recruitment Status : Unknown
Verified August 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : April 8, 2011
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE April 7, 2011
First Posted Date  ICMJE April 8, 2011
Last Update Posted Date August 29, 2017
Actual Study Start Date  ICMJE May 31, 2011
Estimated Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
90-day mortality [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01331863 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
90-day morbidity [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Airway and/or Pulmonary Vessels Transplantation
Official Title  ICMJE Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Tracheal Neoplasm
  • Tracheal Stenosis
Intervention  ICMJE Procedure: Airway and/or pulmonary Vessels Transplantation
Use of a stent-supported aortic allograft to prevent pneumonectomy in lung cancer SURGERY
Study Arms  ICMJE Experimental: single arm surgery
Airway and/or pulmonary Vessels Transplantation
Intervention: Procedure: Airway and/or pulmonary Vessels Transplantation
Publications * Martinod E, Chouahnia K, Radu DM, Joudiou P, Uzunhan Y, Bensidhoum M, Santos Portela AM, Guiraudet P, Peretti M, Destable MD, Solis A, Benachi S, Fialaire-Legendre A, Rouard H, Collon T, Piquet J, Leroy S, Vénissac N, Santini J, Tresallet C, Dutau H, Sebbane G, Cohen Y, Beloucif S, d'Audiffret AC, Petite H, Valeyre D, Carpentier A, Vicaut E. Feasibility of Bioengineered Tracheal and Bronchial Reconstruction Using Stented Aortic Matrices. JAMA. 2018 Jun 5;319(21):2212-2222. doi: 10.1001/jama.2018.4653.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 7, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2018
Estimated Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01331863
Other Study ID Numbers  ICMJE P091203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emmanuel MARTINOD, Pr, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP