PneumothoraxPhase 3NCT02558608
Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence
A Phase 3 study testing DIPL, WR and thoracoscopic surgery in people with Pneumothorax, run by Chinese Medical Association at 1 site in China.
Trial summary
This subject analysis of the influence of the dissociating inferior pulmonary ligament on pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by video assisted thoracic surgery. All patients are randomly divided into two groups: group A and group B. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- DIPL, WR and thoracoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Apr 2020
- 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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The patients diagnosis pneumothorax with chest radiograph or computed tomography (CT)
- The clinical and final pathological diagnosis for patient is PSP.
- The patients with stable vital signs, no contraindication for operation and no communication barriers.
- The patients,after informed of test content, significance and risk, who voluntarily enroll and sign informed consent.
Who cannot join
- The patients who refuse to do a video assisted thoracic surgery.
- The patients with pneumothorax with specific causes such as pulmonary hamartoangiomyomatosis, catamenial pneumothorax, and pneumothorax secondary to chronic obstructive pulmonary disease.
- The patients who were older than 50 years
- The patients with familial history of pneumothorax.
- The patients with mental disorders, low Intelligence Quotient, can not objectively reflect the indicators of observation.
- The patients who refuse to follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Haidian Hospital
Beijing, Beijing Municipality, 100086
Jian Cui, Director, +861082693152, cuijiandoctor@sina.com
About this study
Official title: Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence After Operation by Video-assisted Thoracic Surgery in the Treatment of Primary Spontaneous Pneumothorax(PSP)
This subject analysis of the influence of the dissociating inferior pulmonary ligament on pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by video assisted thoracic surgery. All patients are randomly divided into two groups: group A and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed between the two groups.
Read the detailed description
Wedge resection of the lung is usually used in the treatment of primary spontaneous pneumothorax. And the pleural treatment also might be used. But part of secondary pneumothorax patients who had undergone surgical, the bullae can be found especially in the apical of lung, even if the pleural have been treated in some way.This subject provides a new way of thinking and method to solve the problem of recurrent spontaneous pneumothorax.
- Conditions
- Pneumothorax
- Being tested
- DIPL, WR, thoracoscopic surgery
- Keywords
- Prime Spontaneous Pneumothorax, recurrence
- Medical subject headings
- Pneumothorax, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIPLProcedure or surgery
dissection of the inferior pulmonary ligament
WRProcedure or surgery
wedge resection of the lung bleb
thoracoscopic surgeryProcedure or surgery
surgery performed by video assisted thoracoscopy
| Study group | Role | What they receive |
|---|---|---|
| WR AND DIPL | Experimental | patients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery Receives: Procedure: DIPL; Procedure: WR; Procedure: thoracoscopic surgery |
| WR | Active comparator | patients undergo wedge resection by thoracoscopic surgery or video assisted thoracoscopic surgery without dissection the inferior pulmonary ligament Receives: Procedure: WR; Procedure: thoracoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
the 3- year recurrence rate of pneumothorax after surgery.
Measured: 3 years
Secondary outcomes (1)
pulmonary reexpansion rate
the proportion of pulmonary reexpansion on the first and fourth day after operation.
Measured: 1 day and 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Jian Cui, Beijing Haidian Hospital
- Investigators
- Jian Cui, director, Study director, Beijing Haidian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558608
- Sponsor's protocol ID
- FPL001
- Status last verified
- Oct 2015
- First submitted
- 13 Sep 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baumann MH, Strange C, Heffner JE, Light R, Kirby TJ, Klein J, Luketich JD, Panacek EA, Sahn SA; AACP Pneumothorax Consensus Group. Management of spontaneous pneumothorax: an American College of Chest Physicians Delphi consensus statement. Chest. 2001 Feb;119(2):590-602. doi: 10.1378/chest.119.2.590.
PubMed 11171742Gaunt A, Martin-Ucar AE, Beggs L, Beggs D, Black EA, Duffy JP. Residual apical space following surgery for pneumothorax increases the risk of recurrence. Eur J Cardiothorac Surg. 2008 Jul;34(1):169-73. doi: 10.1016/j.ejcts.2008.03.049. Epub 2008 May 1.
PubMed 18455414Casali C, Stefani A, Ligabue G, Natali P, Aramini B, Torricelli P, Morandi U. Role of blebs and bullae detected by high-resolution computed tomography and recurrent spontaneous pneumothorax. Ann Thorac Surg. 2013 Jan;95(1):249-55. doi: 10.1016/j.athoracsur.2012.05.073. Epub 2012 Jul 10.
PubMed 22785214Min X, Huang Y, Yang Y, Chen Y, Cui J, Wang C, Huang Y, Liu J, Wang J. Mechanical pleurodesis does not reduce recurrence of spontaneous pneumothorax: a randomized trial. Ann Thorac Surg. 2014 Nov;98(5):1790-6; discussion 1796. doi: 10.1016/j.athoracsur.2014.06.034. Epub 2014 Sep 16.
PubMed 25236367Hatz RA, Kaps MF, Meimarakis G, Loehe F, Muller C, Furst H. Long-term results after video-assisted thoracoscopic surgery for first-time and recurrent spontaneous pneumothorax. Ann Thorac Surg. 2000 Jul;70(1):253-7. doi: 10.1016/s0003-4975(00)01411-9.
PubMed 10921718
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence After Operation by Video-assisted Thoracic Surgery in the Treatment of Primary Spontaneous Pneumothorax(PSP)
- ClinicalTrials.gov ID
- NCT02558608
- Acronym / sponsor ID
- FPL001
- Conditions
- Pneumothorax
- Keywords
- Prime Spontaneous Pneumothorax, recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 24 Sep 2015 (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.
This subject analysis of the influence of the dissociating inferior pulmonary ligament on pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by video assisted thoracic surgery. All patients are randomly divided into two groups: group A and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed between the two groups.
Detailed description
Wedge resection of the lung is usually used in the treatment of primary spontaneous pneumothorax. And the pleural treatment also might be used. But part of secondary pneumothorax patients who had undergone surgical, the bullae can be found especially in the apical of lung, even if the pleural have been treated in some way.This subject provides a new way of thinking and method to solve the problem of recurrent spontaneous pneumothorax.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WR AND DIPL | Experimental | Procedure: DIPL, Procedure: WR, Procedure: thoracoscopic surgerypatients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery |
| WR | Active comparator | Procedure: WR, Procedure: thoracoscopic surgerypatients undergo wedge resection by thoracoscopic surgery or video assisted thoracoscopic surgery without dissection the inferior pulmonary ligament |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The patients diagnosis pneumothorax with chest radiograph or computed tomography (CT)
- The clinical and final pathological diagnosis for patient is PSP.
- The patients with stable vital signs, no contraindication for operation and no communication barriers.
- The patients,after informed of test content, significance and risk, who voluntarily enroll and sign informed consent.
Key exclusion criteria (6 listed)
- The patients who refuse to do a video assisted thoracic surgery.
- The patients with pneumothorax with specific causes such as pulmonary hamartoangiomyomatosis, catamenial pneumothorax, and pneumothorax secondary to chronic obstructive pulmonary disease.
- The patients who were older than 50 years
- The patients with familial history of pneumothorax.
- The patients with mental disorders, low Intelligence Quotient, can not objectively reflect the indicators of observation.
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 |
|---|---|---|
| DIPLdissection of the inferior pulmonary ligament | Procedure or surgery | WR AND DIPL |
| WRwedge resection of the lung bleb | Procedure or surgery | WR, WR AND DIPL |
| thoracoscopic surgerysurgery performed by video assisted thoracoscopy | Procedure or surgery | WR, WR AND DIPL |
Primary outcome
recurrence rate
Time frame: 3 years
the 3- year recurrence rate of pneumothorax after surgery.
1 secondary outcome
pulmonary reexpansion rate
Time frame: 1 day and 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Background: PubMed 11171742Baumann MH, Strange C, Heffner JE, Light R, Kirby TJ, Klein J, Luketich JD, Panacek EA, Sahn SA; AACP Pneumothorax Consensus Group. Management of spontaneous pneumothorax: an American College of Chest Physicians Delphi consensus statement. Chest. 2001 Feb;119(2):590-602. doi: 10.1378/chest.119.2.590.
- Background: PubMed 18455414Gaunt A, Martin-Ucar AE, Beggs L, Beggs D, Black EA, Duffy JP. Residual apical space following surgery for pneumothorax increases the risk of recurrence. Eur J Cardiothorac Surg. 2008 Jul;34(1):169-73. doi: 10.1016/j.ejcts.2008.03.049. Epub 2008 May 1.
- Background: PubMed 22785214Casali C, Stefani A, Ligabue G, Natali P, Aramini B, Torricelli P, Morandi U. Role of blebs and bullae detected by high-resolution computed tomography and recurrent spontaneous pneumothorax. Ann Thorac Surg. 2013 Jan;95(1):249-55. doi: 10.1016/j.athoracsur.2012.05.073. Epub 2012 Jul 10.
- Background: PubMed 25236367Min X, Huang Y, Yang Y, Chen Y, Cui J, Wang C, Huang Y, Liu J, Wang J. Mechanical pleurodesis does not reduce recurrence of spontaneous pneumothorax: a randomized trial. Ann Thorac Surg. 2014 Nov;98(5):1790-6; discussion 1796. doi: 10.1016/j.athoracsur.2014.06.034. Epub 2014 Sep 16.
- Background: PubMed 10921718Hatz RA, Kaps MF, Meimarakis G, Loehe F, Muller C, Furst H. Long-term results after video-assisted thoracoscopic surgery for first-time and recurrent spontaneous pneumothorax. Ann Thorac Surg. 2000 Jul;70(1):253-7. doi: 10.1016/s0003-4975(00)01411-9.
Related trials for Pneumothorax
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
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
Not yet recruitingObservational study
The Impact of Artificial Intelligence-Assisted X-ray Interpretation on Radiologists' Diagnostic Performance
Pneumothorax, Intestinal Obstruction
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.
Jian Cui, director study director
Beijing Haidian Hospital
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 DIPL, WR and thoracoscopic surgery in people with Pneumothorax, run by Chinese Medical Association at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Oct 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Cui, director (+861082693152, cuijiandoctor@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate (time frame: 3 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 NCT02558608, which also lists 5 linked publications.
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 Oct 2015.