PneumothoraxNCT00767962
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
A study testing talc pleurodesis under medical thoracoscopy and pleurodesis under video-assisted thoracoscopy surgery in people with Pneumothorax, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- talc pleurodesis under medical thoracoscopy and pleurodesis under video-assisted thoracoscopy surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Oncologie Thoracique- Hôpital Sainte Marguerite
Marseille, 13274
About this study
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.
Read the 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.
- Conditions
- Pneumothorax
- Being tested
- talc pleurodesis under medical thoracoscopy, pleurodesis under video-assisted thoracoscopy surgery
- Keywords
- recurrent primary spontaneous pneumothorax
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talc pleurodesis under medical thoracoscopyOther
talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax
pleurodesis under video-assisted thoracoscopy surgeryOther
pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | talc pleurodesis under medical thoracoscopy Receives: Other: talc pleurodesis under medical thoracoscopy |
| 2 | Other | pleurodesis under video-assisted thoracoscopy surgery Receives: Other: pleurodesis under video-assisted thoracoscopy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
to show the non-inferiority of talc pleurodesis under medical thoracoscopy versus pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne FRATICELLI, MD, Principal investigator, Assistance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767962
- Sponsor's protocol ID
- 2007-A00342-51
- Status last verified
- Aug 2015
- First submitted
- 6 Oct 2008
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00767962
- Acronym / sponsor ID
- 2007-A00342-51
- Conditions
- Pneumothorax
- Keywords
- recurrent primary spontaneous pneumothorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: talc pleurodesis under medical thoracoscopytalc pleurodesis under medical thoracoscopy |
| 2 | Other | Other: pleurodesis under video-assisted thoracoscopy surgerypleurodesis under video-assisted thoracoscopy surgery |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| talc pleurodesis under medical thoracoscopytalc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax | Other | 1 |
| pleurodesis under video-assisted thoracoscopy surgerypleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax | Other | 2 |
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
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne FRATICELLI, MD principal investigator
Assistance Publique des Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing talc pleurodesis under medical thoracoscopy and pleurodesis under video-assisted thoracoscopy surgery in people with Pneumothorax, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.