Airway and/or Pulmonary Vessels Transplantation

NCT01331863 | Completed Phase 1 DMC

• 1 other identifier: P091203
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Tracheal Neoplasm; Tracheal Stenosis

Keywords

Bronchial disease; Lung cancer surgery; Aorta/aortic Allograft; homograft; Tracheal disease; Benign; Malignant

Outcome Measures

Primary Outcomes (1)

• 90-day mortality

  3 months

Secondary Outcomes (1)

• 90-day morbidity

  90 days

Study Arms (1)

single arm surgery

EXPERIMENTAL

Airway and/or pulmonary Vessels Transplantation

Procedure: Airway and/or pulmonary Vessels Transplantation

Interventions

Airway and/or pulmonary Vessels Transplantation PROCEDURE

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

single arm surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris, Hôpital Avicenne, CHU Paris-Seine-Saint-Denis

Bobigny, Seine-Saint-Denis, 93000, France

Location

Related Publications (1)

• 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, Venissac 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.

  PMID: 29800033 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Tracheal Neoplasms; Tracheal Stenosis; Bronchial Diseases; Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Head and Neck Neoplasms

Study Officials

• Emmanuel MARTINOD, Pr, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 8, 2011
• Study Start: May 31, 2011
• Primary Completion: August 31, 2018
• Study Completion: November 30, 2018
• Last Updated: September 9, 2020

Record last verified: 2017-08

Locations

FR (1)