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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00767962
Other study ID # 2007-A00342-51
Secondary ID
Status Completed
Phase N/A
First received October 6, 2008
Last updated August 21, 2015
Start date February 2009
Est. completion date December 2014

Study information

Verified date August 2015
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

Treatment of recurrent primary spontaneous pneumothorax remains controversial and many therapeutic options exist. The aim of this study is to compare pleural symphysis by talc poudrage during medical thoracoscopy and surgical management combining pleural abrasion and blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.


Description:

Treatment of recurrent primary spontaneous pneumothorax remains controversial and many therapeutic options exist. What is the best technical option : treatment of the lung and the parietal pleura or treatment of the pleura with pleural symphysis ? Talc pleurodesis performed during medical thoracoscopy and resection of blebs or bullae associated with pleural abrasion during surgical thoracoscopy (or video-assisted thoracic surgery) are the most usual methods. These two procedures have never been compared in a prospective trial. The aim of this study is to compare pleural symphysis by talc poudrage during medical thoracoscopy and surgical management combining pleural abrasion and blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 55 Years
Eligibility Inclusion Criteria:

- Subjects :both sexes, who the age is included between 18 years and 55 years;

- Presenting a recurrence homolaterale or controlaterale of a primary spontaneous pneumothorax;

- Presenting a bilateral primary spontaneous pneumothorax

- Presenting a failure of a manual inhalation for a primary spontaneous pneumothorax;

- Presenting a persistent superior bullage at 48 am after a thoracic drainage for a spontaneous pneumothorax

- Presenting a persistent superior bullage at 48 am after a thoracic drainage for a primary spontaneous pneumothorax;

- Presenting a persistent superior unsticking at 48 am after a thoracic drainage for a primary spontaneous pneumothorax;

- Presenting a first episode of pneumothorax spontaneous primary with risk factor of recurrence

- The unsticking must be complete or important (superior to 3 cms between the summit of the lung and the summit of the thoracic cavity or superior to 2 cms with regard to the side thoracic wall);

- Benefiting from a national insurance scheme;

- Agreeing to participate in the study, and having read, included and signed the note of information intended in patients.

Exclusion Criteria:

- Subjects:Presenting a traumatic pneumothorax; Presenting a pneumothorax iatrogène; Presenting a secondary spontaneous pneumothorax ( underlying pleuro-lung pathology); Presenting bubbles of emphysema of size(cutting) superior to 5 cms; presenting a pneumothorax catamenial;Presenting one of the following concomitant severe pathologies dissuading a general anesthetic or any symphysant gesture(movement): cardiac insufficiency

- Pregnant or breast-feeding Woman;

- presenting neurological disorders or psychiatric forbidding the understanding of the essay;

- Who the follow-up is impossible;

- Deprived of freedom following a court or administrative order;

- Not having signed the enlightened assent.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
talc pleurodesis under medical thoracoscopy
talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax
pleurodesis under video-assisted thoracoscopy surgery
pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax

Locations

Country Name City State
France Service d'Oncologie Thoracique- Hôpital Sainte Marguerite Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary to show the non-inferiority of talc pleurodesis under medical thoracoscopy versus pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax 36 months No
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