We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 10 for:    Recruiting, Not yet recruiting, Available Studies | "Tracheal Diseases"

Airway and/or Pulmonary Vessels Transplantation (TRACHBRONCAR)

This study is currently recruiting participants.
Verified August 2017 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331863
First Posted: April 8, 2011
Last Update Posted: August 29, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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 Tracheal Stenosis Procedure: Airway and/or pulmonary Vessels Transplantation Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • 90-day morbidity [ Time Frame: 90 days ]

Estimated Enrollment: 30
Actual Study Start Date: May 31, 2011
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: August 31, 2018 (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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01331863     History of Changes
Other Study ID Numbers: P091203
First Submitted: April 7, 2011
First Posted: April 8, 2011
Last Update Posted: August 29, 2017
Last Verified: August 2017

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
Tracheal Stenosis
Tracheal Neoplasms
Respiratory Tract Diseases
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs