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Completed

NCT Number: NCT00767962

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

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.

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Key information

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Oncologie Thoracique- Hôpital Sainte Marguerite

Marseille, 13274, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

talc pleurodesis under medical thoracoscopy

Other

talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax

pleurodesis under video-assisted thoracoscopy surgery

Other

pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2008
Registry last updated
Aug 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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