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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

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ClinicalTrials.gov Identifier: NCT00767962
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Pneumothorax Other: talc pleurodesis under medical thoracoscopy Other: pleurodesis under video-assisted thoracoscopy surgery Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
1
talc pleurodesis under medical thoracoscopy
 Other: talc pleurodesis under medical thoracoscopy
talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax
2
pleurodesis under video-assisted thoracoscopy surgery
 Other: pleurodesis under video-assisted thoracoscopy surgery
pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. to show the non-inferiority of talc pleurodesis under medical thoracoscopy versus pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax [ Time Frame: 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767962


Locations
France
Service d'Oncologie Thoracique- Hôpital Sainte Marguerite
Marseille, France, 13274
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Anne FRATICELLI, MD Assistance Publique des Hopitaux de Marseille
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00767962     History of Changes
Other Study ID Numbers: 2007-A00342-51
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Assistance Publique Hopitaux De Marseille:
recurrent primary spontaneous pneumothorax

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases