Primary Spontaneous PneumothoraxEarly Phase 1TOPPNCT02866305
Study Designed to Optimize the Treatment of Primary Pneumothorax
A Early Phase 1 study testing VATS bullectomy and mechanical pleuradesis., Chest tube insertion and Epidural in people with Primary Spontaneous Pneumothorax and Pleural Disease, run by Odense University Hospital at 3 sites in Denmark.
Trial summary
Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.The Aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Primary Spontaneous Pneumothorax, Pleural Disease
- What is being tested?
- VATS bullectomy and mechanical pleuradesis., Chest tube insertion and Epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesDenmark
- Study dates
- Mar 2009to Dec 2024
- Phase
- Early Phase 1
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- First incidence of primary spontaneous pneumothorax.
- Age between 18 and 40.
- No known preexisting pulmonary disease.
- Patient must accept randomization.
- Able to read and understand information regarding the study.
- The condition must require treatment with a chest-tube.
Who cannot join
- Age above 40.
- Previously pulmonary og cardiac surgery.
- Pregnant or breastfeeding.
- Patients who do not tolerate anesthetics.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites, 3 recruiting
- Recruiting
Research Unit at the Cardiothoracic Department af Ålborg Hospital
Aalborg, North Denmark, 9100
Jesper Eske Sindby, resident
- Recruiting
Research Unit at the Cardiothoracic Department at the University Hospital of Skejby
Aarhus, Central Jutland, 8600
Niels Katballe, MD, ph.d.
- Recruiting
Research Unit at the cardiothoracic departement at the University Hospital of Odense
Odense, Fyn, 5690
Winnie Hedevang Olesen, ph.d.student, 0045-22947131, winnieholesen@rsyd.dk
Peter Bjørn Licht, Professor, 0045-65413385, peter.licht@ouh.regionsyddanmark.dk
About this study
Official title: Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial
Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.The Aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic predispositions.
Read the detailed description
- Background Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial. Typically, the first incidence is treated conservatively with simple chest tube drainage and only if the disease reoccurs is surgery considered. However, conventional treatment may be associated with increased morbidity, prolonged hospitalization and many young adults are concerned about the high recurrence of this disease. The latter has been reported in as many as 25-35% of patients. Because spontaneous pneumothorax in young adults usually is associated with apical blebs, the investigators hypothesized that primary surgery (Video-Assisted Thoracoscopic Surgery = VATS) with resection of such blebs at the time of the first episode of pneumothorax might be an effective first line treatment associated with lower morbidity and shorter hospital stays, and a definite decline in recurrence rate.
- Method From July 2009 the investigators conducted a nationwide study , where 300 consecutive patients admitted to a Danish hospital with primary spontaneous pneumothorax undergo a high resolution CT of the thorax. Based upon the CT the patients are randomised to conventional conservative treatment (chest tube drainage) or primary VATS with bleb resection and mechanical pleurodesis.
Participants are followed for ten years. The primary endpoint is ipsilateral recurrence of pneumothorax. Secondary endpoints are length of hospitalization, duration of chest tube drainage and miscellaneous complications.
Simultaneously, a research biobank containing blood samples and pulmonary tissue is created for future studies of biomarkers and possible genetic causes.
Finally, the investigators are conducting a national epidemiological study, where the incidence in the Danish population is investigated.
*Perspective This study contributes new knowledge on incidence, genetics and best treatment of primary spontaneous pneumothorax in young adults which will have an impact on the future strategy of both understanding and treatment of this disease on a global level.
- Conditions
- Primary Spontaneous Pneumothorax, Pleural Disease
- Being tested
- VATS bullectomy and mechanical pleuradesis., Chest tube insertion, Epidural, High-resolution Computer Tomography
- Keywords
- primary spontaneous pneumothorax, epidemiology, genetics, risk factors
- Medical subject headings
- Pneumothorax, Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS bullectomy and mechanical pleuradesis.Procedure or surgery
Thoracoscopic bullectomy is performed on all visible bullae, alternatively is no visible bullae, the apex is resected. Then mechanical pleuradesis is performed.
Chest tube insertionProcedure or surgery
Conventional chest tube insertion.
EpiduralDrug
Also called Pain- catheter
All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.
High-resolution Computer TomographyRadiation
All participants included in this study had a HRCT performed.
| Study group | Role | What they receive |
|---|---|---|
| HRCT with bullae, treatment conservative | Experimental | Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage. Receives: Procedure: Chest tube insertion; Radiation: High-resolution Computer Tomography |
| HRCT no bullae, treatment conservative | Experimental | Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage. Receives: Procedure: Chest tube insertion; Radiation: High-resolution Computer Tomography |
| HRCT with bullae, treatment VATS. | Experimental | Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis. Receives: Procedure: VATS bullectomy and mechanical pleuradesis.; Procedure: Chest tube insertion; Drug: Epidural; Radiation: High-resolution Computer Tomography |
| HRCT no bullae, treatment VATS. | Experimental | Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis. Receives: Procedure: VATS bullectomy and mechanical pleuradesis.; Procedure: Chest tube insertion; Drug: Epidural; Radiation: High-resolution Computer Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ipsilateral recurrence
All participants are followed 10 years from the initial discharge via Questionnaires
Measured: 10 years
Secondary outcomes (3)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 10 years
Length of hospital stay
Length of initial hospital stay
Measured: up to 10 years
Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startMar 2009
- Primary completionDec 2017 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Spontaneous PneumothoraxStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Medical Association, Danmarks Lungeforening
- Responsible party
- Principal investigator, Winnie Hedevang Olesen, Odense University Hospital
- Investigators
- Winnie Hedevang Olesen, ph.d.student, Study director, Research Unit at the Cardiothoracic Department at the University Hospital of Odense.Peter Bjørn Licht, Professor MD, Principal investigator, Research Unit at the Cardiothoracic Department at the University Hospital of Odense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866305
- Sponsor's protocol ID
- TOPP2009
- Acronym
- TOPP
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2010
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Olesen WH, Katballe N, Sindby JE, Titlestad IL, Andersen PE, Lindahl-Jacobsen R, Licht PB. Surgical treatment versus conventional chest tube drainage in primary spontaneous pneumothorax: a randomized controlled trial. Eur J Cardiothorac Surg. 2018 Jul 1;54(1):113-121. doi: 10.1093/ejcts/ezy003.
PubMed 29509892
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02866305
- Acronym / sponsor ID
- TOPP / TOPP2009
- Conditions
- Primary Spontaneous Pneumothorax, Pleural Disease
- Keywords
- primary spontaneous pneumothorax, epidemiology, genetics, risk factors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Danish Medical Association, Danmarks Lungeforening
- Study start
- Mar 2009
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Aug 2016 (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.
Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.The Aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic predispositions.
Detailed description
- Background Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial. Typically, the first incidence is treated conservatively with simple chest tube drainage and only if the disease reoccurs is surgery considered. However, conventional treatment may be associated with increased morbidity, prolonged hospitalization and many young adults are concerned about the high recurrence of this disease. The latter has been reported in as many as 25-35% of patients. Because spontaneous pneumothorax in young adults usually is associated with apical blebs, the investigators hypothesized that primary surgery (Video-Assisted Thoracoscopic Surgery = VATS) with resection of such blebs at the time of the first episode of pneumothorax might be an effective first line treatment associated with lower morbidity and shorter hospital stays, and a definite decline in recurrence rate.
- Method From July 2009 the investigators conducted a nationwide study , where 300 consecutive patients admitted to a Danish hospital with primary spontaneous pneumothorax undergo a high resolution CT of the thorax. Based upon the CT the patients are randomised to conventional conservative treatment (chest tube drainage) or primary VATS with bleb resection and mechanical pleurodesis.
Participants are followed for ten years. The primary endpoint is ipsilateral recurrence of pneumothorax. Secondary endpoints are length of hospitalization, duration of chest tube drainage and miscellaneous complications.
Simultaneously, a research biobank containing blood samples and pulmonary tissue is created for future studies of biomarkers and possible genetic causes.
Finally, the investigators are conducting a national epidemiological study, where the incidence in the Danish population is investigated.
*Perspective This study contributes new knowledge on incidence, genetics and best treatment of primary spontaneous pneumothorax in young adults which will have an impact on the future strategy of both understanding and treatment of this disease on a global level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HRCT with bullae, treatment conservative | Experimental | Procedure: Chest tube insertion, Radiation: High-resolution Computer TomographyPatients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage. |
| HRCT no bullae, treatment conservative | Experimental | Procedure: Chest tube insertion, Radiation: High-resolution Computer TomographyPatients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage. |
| HRCT with bullae, treatment VATS. | Experimental | Procedure: VATS bullectomy and mechanical pleuradesis., Procedure: Chest tube insertion, Drug: Epidural, Radiation: High-resolution Computer TomographyPatients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis. |
| HRCT no bullae, treatment VATS. | Experimental | Procedure: VATS bullectomy and mechanical pleuradesis., Procedure: Chest tube insertion, Drug: Epidural, Radiation: High-resolution Computer TomographyPatients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- First incidence of primary spontaneous pneumothorax.
- Age between 18 and 40.
- No known preexisting pulmonary disease.
- Patient must accept randomization.
- Able to read and understand information regarding the study.
Key exclusion criteria (4 listed)
- Age above 40.
- Previously pulmonary og cardiac surgery.
- Pregnant or breastfeeding.
- Patients who do not tolerate anesthetics.
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 |
|---|---|---|
| VATS bullectomy and mechanical pleuradesis.Thoracoscopic bullectomy is performed on all visible bullae, alternatively is no visible bullae, the apex is resected. Then mechanical pleuradesis is performed. | Procedure or surgery | HRCT no bullae, treatment VATS., HRCT with bullae, treatment VATS. |
| Chest tube insertionConventional chest tube insertion. | Procedure or surgery | HRCT no bullae, treatment VATS., HRCT no bullae, treatment conservative, HRCT with bullae, treatment VATS., HRCT with bullae, treatment conservative |
| EpiduralAlso: Pain- catheterAll surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube. | Drug | HRCT no bullae, treatment VATS., HRCT with bullae, treatment VATS. |
| High-resolution Computer TomographyAll participants included in this study had a HRCT performed. | Radiation | HRCT no bullae, treatment VATS., HRCT no bullae, treatment conservative, HRCT with bullae, treatment VATS., HRCT with bullae, treatment conservative |
Primary outcome
Time to ipsilateral recurrence
Time frame: 10 years
All participants are followed 10 years from the initial discharge via Questionnaires
3 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 10 years
Length of hospital stay
Time frame: up to 10 years
Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years.
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Derived from this study: PubMed 29509892Olesen WH, Katballe N, Sindby JE, Titlestad IL, Andersen PE, Lindahl-Jacobsen R, Licht PB. Surgical treatment versus conventional chest tube drainage in primary spontaneous pneumothorax: a randomized controlled trial. Eur J Cardiothorac Surg. 2018 Jul 1;54(1):113-121. doi: 10.1093/ejcts/ezy003.
- Individual participant dataSharing planned: No
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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.
Winnie Hedevang Olesen, ph.d.student study director
Research Unit at the Cardiothoracic Department at the University Hospital of Odense.
Peter Bjørn Licht, Professor MD principal investigator
Research Unit at the Cardiothoracic Department at the University Hospital of Odense
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing VATS bullectomy and mechanical pleuradesis., Chest tube insertion and Epidural in people with Primary Spontaneous Pneumothorax and Pleural Disease, run by Odense University Hospital at 3 sites in Denmark.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Winnie Hedevang Olesen, ph.d.student (0045-22947131, winnie.olesen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ipsilateral recurrence (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02866305, which also lists 1 linked publication.
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 16 Aug 2016.