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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00767962
First received: October 6, 2008
Last updated: May 18, 2010
Last verified: May 2010
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Purpose
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 | Intervention |
|---|---|
|
Pneumothorax |
Other: talc pleurodesis under medical thoracoscopy Other: pleurodesis under video-assisted thoracoscopy surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Assistance Publique Hopitaux De Marseille:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 15 Years to 55 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767962
Contacts
| Contact: Anne FRATICELLI, MD | 0491744736 | anne.fraticelli@mail.ap-hm.fr |
Locations
| France | |
| Service d'Oncologie Thoracique- Hôpital Sainte Marguerite | Recruiting |
| Marseille, France, 13274 | |
| Contact: Anne FRATICELLI, MD 0491744736 anne.fraticelli@mail.ap-hm.fr | |
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
| Principal Investigator: | Anne FRATICELLI, MD | Assistance Publique des Hopitaux de Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT00767962 History of Changes |
| Other Study ID Numbers: | 2007-A00342-51 |
| Study First Received: | October 6, 2008 |
| Last Updated: | May 18, 2010 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
recurrent primary spontaneous pneumothorax |
Additional relevant MeSH terms:
|
Pneumothorax Pleural Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013