Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers
- Conditions
- Lung NeoplasmCarcinoma, Non-Small-Cell Lung
- Interventions
- Device: silicone trachea-bronchial stent Dumon (Novatech)
- Registration Number
- NCT01064050
- Brief Summary
A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of lung cancers with a high impact on survival and quality of life of these patients. The endoluminal resection of these tumors through interventional bronchoscopy can remove the tumor but fails to prevent the recurrence. A stent insertion could achieve this goal but this option was never proved in a prospective protocol.
The aim of this study is to analyze the impact of stent insertion on the survival without symptoms of bronchial obstruction in patients treated for their cancer with and without a first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients with stent insertion) with a control arm (170 patients without stent). The inclusion period will last 3 years with one year of follow-up for each patient. The one-year survival without symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) will be the main endpoint. All patients without symptomatic recurrence at one year will be controlled endoscopically. Survival and stent tolerance will be studied as secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each endoscopical situation (before and after resection, recurrence or side effects of stents) will be analyzed and registered by an independent committee of 3 international experts.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 75
- > 18 years
- non-small cell lung cancer,
- inoperable and location : tracheal, carinal, main bronchus right or left, or intermediate trunk.
- TNM stage known and oncological treatment later determined
- central initial intrinsic bronchial obstruction > 50%.
- resection of tumor with endoscopy, to obtain after therapeutic bronchoscopy a diameter > 50% normal diameter of bronchial segment achieved.
- Tumoral segment fully recoverable by a stent
- Written consent, free and informed
- Patient affiliated or who is entitled to to a social security scheme.
- against-indication for general anesthesia.
- Patient with one lung not working beyond the stenosis
- Patient under guardianship
- Pregnancy
- 12 months follow-up impossible
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description trachea-bronchial stent (Novatech) silicone trachea-bronchial stent Dumon (Novatech) -
- Primary Outcome Measures
Name Time Method Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) 12 months
- Secondary Outcome Measures
Name Time Method For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months. 12 months Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy. 12 months Quality of life : EORTC 12 months death 12 months
Trial Locations
- Locations (13)
Departement of pneumology, CHU Brest
🇫🇷Brest, France
Pneumology departement, CHRU Lille
🇫🇷Lille, France
Department of pneumology, CHU Amiens
🇫🇷Amiens, France
Pneumology departement, Hôpital Percy
🇫🇷Clamart, France
Pneumology departement, Sainte Marguerite hospital
🇫🇷Marseille, France
Pneumology departement, CHU Limoges
🇫🇷Limoges, France
Pneumology departement, CHU Nantes
🇫🇷Nantes, France
Pneumology departement, Saint-Antoine hospital
🇫🇷Paris, France
Department of respiratory diseases and allergic, Thoracic Oncology, CHU Reims
🇫🇷Reims, France
Pneumology Clinic - Albert Calmette hospital- CHU Rouen
🇫🇷Rouen, France
Pneumology departement CHU Saint-Etienne
🇫🇷Saint-etienne, France
Endoscopy unit, Thoracic surgery department, Foch Hospital
🇫🇷Suresnes, France
Departement of pneumology, CHU TOULOUSE
🇫🇷Toulouse, France