A Prospective Randomised Study of Efficacy, Safety and Costs of Talc Pleurodesis Under Medical Thoracoscopy and Pleurodesis Under Video-assisted Thoracoscopy Surgery for Recurrent Primary Spontaneous Pneumothorax

Pneumothorax Clinical Trial

Official title:

A Prospective Randomised Study of Efficacy, Safety and Costs of Talc Pleurodesis Under Medical Thoracoscopy and Pleurodesis Under Video-assisted Thoracoscopy Surgery for Recurrent Primary Spontaneous Pneumothorax

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767962
• Other study ID #: 2007-A00342-51
• 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

• Pneumothorax

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