Primary Spontaneous PneumothoraxPhase 3NCT00615849
Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax
A Phase 3 study testing thoracoscopic surgery in people with Primary Spontaneous Pneumothorax, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. But additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Primary Spontaneous Pneumothorax
- What is being tested?
- thoracoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,440 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2006to Jul 2011
- Phase
- Phase 3
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- recurrent pneumothorax
- bilateral pneumothorax
- total collapse/tension pneumothorax
- previous history of contralateral pneumothorax
- visible bulla on simple X-ray
- special occupation/situation
- air leakage more than 2 days with drainage catheter for 1st attack patients
Who cannot join
- patient refusal and reoperation case
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seungnam, Gyeonggi-do, 463-707
About this study
Official title: Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax
For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. But additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural physiology and cause chronic pain. According to our previous study, stapling resection of the bulla without pleurodesis gave comparable result in recurrence comparing with articles with additional pleurodesis. The purpose of this study is to evaluate surgical outcome of thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure is essential in the management of PSP.
- Conditions
- Primary Spontaneous Pneumothorax
- Being tested
- thoracoscopic surgery
- Keywords
- pneumothorax, thoracoscopy, pleurodesis
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracoscopic surgeryProcedure or surgery
stapled wedge resection of the lung mechanical pleural abrasion
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
Measured: follow up more than 1 year
Secondary outcomes (1)
complications
Measured: follow up more than 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startNov 2006
- Primary completionJul 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Spontaneous PneumothoraxStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanghoon Jheon, Seoul National University Bundang Hospital
- Investigators
- Sanghoon Jheon, M.D., Ph.D., Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615849
- Sponsor's protocol ID
- KPT
- Status last verified
- Sep 2011
- First submitted
- 1 Feb 2008
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax
- ClinicalTrials.gov ID
- NCT00615849
- Acronym / sponsor ID
- KPT
- Conditions
- Primary Spontaneous Pneumothorax
- Keywords
- pneumothorax, thoracoscopy, pleurodesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Feb 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.
For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. But additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural physiology and cause chronic pain. According to our previous study, stapling resection of the bulla without pleurodesis gave comparable result in recurrence comparing with articles with additional pleurodesis. The purpose of this study is to evaluate surgical outcome of thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure is essential in the management of PSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- recurrent pneumothorax
- bilateral pneumothorax
- total collapse/tension pneumothorax
- previous history of contralateral pneumothorax
- visible bulla on simple X-ray
Key exclusion criteria (1 listed)
- patient refusal and reoperation case
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 |
|---|---|---|
| thoracoscopic surgerystapled wedge resection of the lung mechanical pleural abrasion | Procedure or surgery | – |
Primary outcome
recurrence
Time frame: follow up more than 1 year
1 secondary outcome
complications
Time frame: follow up more than 1 year
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 30 Sep 2011.
Related trials for Primary Spontaneous Pneumothorax
Not yet recruitingPhase 2/3
Stop Air Leak by Talc or Autologous Blood Patch Therapy
Pneumothorax Spontaneous Secondary
Active, not recruiting
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Pneumothorax Spontaneous Primary
Enrolling by invitation
Evaluating the Use of an App in Pleural Disease: Algorithm-supported Clinical Decision Making Versus Usual Care
Pleural Diseases, Pneumothorax Spontaneous Primary
Not yet recruiting
Conservative Management in Primary Spontaneous Pneumothorax: a Multicenter Randomized Non-inferiority Study
Primary Spontaneous Pneumothorax (PSP), Conservative Management (Active Observation)
Not yet recruiting
Comparison of Talc Slurry Versus Talc Insufflation: A Study on Effectiveness, Safety, and Hospital Outcomes in Pleurodesis
Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary
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.
Sanghoon Jheon, M.D., Ph.D. principal investigator
Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing thoracoscopic surgery in people with Primary Spontaneous Pneumothorax, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 7 inclusion and 1 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 30 Sep 2011. 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 South Korea. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
recurrence (time frame: follow up more than 1 year). 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 30 Sep 2011.