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.

Study Overview

• Status: Completed
• Conditions: Pneumothorax
• Intervention / Treatment: Other: talc pleurodesis under medical thoracoscopy; Other: pleurodesis under video-assisted thoracoscopy surgery

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13274
    • Service d'Oncologie Thoracique- Hôpital Sainte Marguerite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 51 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; talc pleurodesis under medical thoracoscopy	Other: talc pleurodesis under medical thoracoscopy; talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Anne FRATICELLI, MD, Assistance Publique Des Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 6, 2008
• First Submitted That Met QC Criteria: October 6, 2008
• First Posted (Estimate): October 7, 2008

Study Record Updates

• Last Update Posted (Estimate): August 24, 2015
• Last Update Submitted That Met QC Criteria: August 21, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: recurrent primary spontaneous pneumothorax
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: 2007-A00342-51