Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers (SPOC)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Neoplasm Carcinoma, Non-Small-Cell Lung |
Device: silicone trachea-bronchial stent Dumon (Novatech) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study) |
- Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Quality of life : EORTC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 75 |
| Study Start Date: | November 2008 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: trachea-bronchial stent (Novatech) |
Device: silicone trachea-bronchial stent Dumon (Novatech)
Bronchial desobstruction under interventional bronchoscopy, for inclusion, with the insertion of silicone stent trachea-bronchial covering the entire tumor area
|
| No Intervention: control |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 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.
Exclusion Criteria:
- against-indication for general anesthesia.
- Patient with one lung not working beyond the stenosis
- Patient under guardianship
- Pregnancy
- 12 months follow-up impossible
Contacts and Locations| France | |
| Department of pneumology, CHU Amiens | |
| Amiens, France | |
| Departement of pneumology, CHU Brest | |
| Brest, France | |
| Pneumology departement, Hôpital Percy | |
| Clamart, France | |
| Pneumology departement, CHRU Lille | |
| Lille, France | |
| Pneumology departement, CHU Limoges | |
| Limoges, France | |
| Pneumology departement, Sainte Marguerite hospital | |
| Marseille, 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, 42055 | |
| Endoscopy unit, Thoracic surgery department, Foch Hospital | |
| Suresnes, France | |
| Departement of pneumology, CHU TOULOUSE | |
| Toulouse, France | |
| Principal Investigator: | Jean-Michel Vergnon, MD PhD | CHU SAINT-ETIENNE |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT01064050 History of Changes |
| Other Study ID Numbers: | 0708042, 2007-A01190-53 |
| Study First Received: | February 2, 2010 |
| Last Updated: | May 16, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: French Data Protection Authority |
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
|
tumoral obstruction of the main stem bronchus bronchoscopy silicone stent |
Additional relevant MeSH terms:
|
Airway Obstruction Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Recurrence Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013