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Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)


Phase 4
18 Years
N/A
Not Enrolling
Both
Lung Neoplasm, Carcinoma, Non-Small-Cell Lung

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Trial Information

Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone)

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Jean-Michel Vergnon, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU SAINT-ETIENNE

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0708042

NCT ID:

NCT01064050

Start Date:

November 2008

Completion Date:

May 2012

Related Keywords:

  • Lung Neoplasm
  • Carcinoma, Non-Small-Cell Lung
  • tumoral obstruction of the main stem bronchus
  • bronchoscopy
  • silicone stent
  • Airway Obstruction
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Recurrence

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