Clinical trial · Interventional
Airway and/or Pulmonary Vessels Transplantation
Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Tracheal Neoplasm | Tracheal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Tracheal Stenosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Airway and/or pulmonary Vessels Transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm surgery
- description
- Airway and/or pulmonary Vessels Transplantation
- interventionNames
- Procedure: Airway and/or pulmonary Vessels Transplantation
Primary outcomes (1)
- measure
- 90-day mortality
- timeFrame
- 3 months
Secondary outcomes (1)
- measure
- 90-day morbidity
- timeFrame
- 90 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMartinod 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