- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01331863
Airway and/or Pulmonary Vessels Transplantation (TRACHBRONCAR)
Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft
- 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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-
Seine-Saint-Denis
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Bobigny, Seine-Saint-Denis, Frankrig, 93000
- Assistance Publique Hôpitaux de Paris, Hôpital Avicenne, CHU Paris-Seine-Saint-Denis
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: single arm surgery
Airway and/or pulmonary Vessels Transplantation
|
Use of a stent-supported aortic allograft to prevent pneumonectomy in lung cancer SURGERY
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
90-day mortality
Tidsramme: 3 months
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
90-day morbidity
Tidsramme: 90 days
|
90 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Emmanuel MARTINOD, Pr, PhD, Assistance Publique - Hôpitaux de Paris
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P091203
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