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
Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumothorax
Intervention: talc pleurodesis under medical thoracoscopy (Other); pleurodesis under video-assisted thoracoscopy surgery (Other)
Phase: N/A
Status: Completed
Sponsored by: Assistance Publique Hopitaux De Marseille Official(s) and/or principal investigator(s):
Anne FRATICELLI, MD, Principal Investigator, Affiliation: Assistance Publique des Hopitaux de Marseille
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: to show the non-inferiority of talc pleurodesis under medical thoracoscopy versus pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax
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.
Eligibility
Minimum age: 15 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Service d'Oncologie Thoracique- Hôpital Sainte Marguerite, Marseille 13274, France
Additional Information
Starting date: February 2009
Last updated: August 21, 2015
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