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

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
|
- 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 ]

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

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
France | |
Service d'Oncologie Thoracique- Hôpital Sainte Marguerite | |
Marseille, France, 13274 |
Principal Investigator: | Anne FRATICELLI, MD | Assistance Publique des Hopitaux de Marseille |
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 |