Spontaneous PneumothoraxPhase 2/3NCT01848860
Absorbable Mesh Pleurodesis in Thoracoscopic Treatment of Spontaneous Pneumothorax
A Phase 2/3 study testing Thoracoscopic bullectomy and pleural abrasion and Mesh coverage of the staple line in people with Spontaneous Pneumothorax and Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Primary spontaneous pneumothorax usually occurs in young, lean male without underlying lung disease. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the lung. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Spontaneous Pneumothorax, Surgery
- What is being tested?
- Thoracoscopic bullectomy and pleural abrasion and Mesh coverage of the staple line
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2013to Dec 2018
- Phase
- Phase 2/3
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 15 and 50 years old.
- Spontaneous pneumothorax requiring thoracoscopic surgery.
- With written inform consent
Who cannot join
- With underlying pulmonary disease (chronic obstructive pulmonary disease, bronchiectasis, tuberculosis, etc)
- A history of previous ipsilateral thoracic operation
- Diagnosis of catamenial pneumothorax
- Diagnosis of lymphangioleiomyomatosis
- Concurrent hemopneumothorax with bleeding > 500ml/h
- Pregnant or lactating women
Show all 12Show fewer
- Other serious concomitant illness or medical conditions:
- Congestive heart failure or unstable angina pectoris.
- History of myocardial infarction within 1 year prior to the study entry.
- Uncontrolled hypertension or arrhythmia.
- History of significant neurologic or psychiatric disorders, including dementia or seizure.
- Active infection requiring i.v. antibiotics.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Jin-Shing Chen, MD, PhD, 02-23123456 ext. 65178, chenjs@ntu.edu.tw
Jin-Shing Chen, MD, PhD
About this study
Official title: Thoracoscopic Bullectomy With Absorbable Mesh Coverage of the Staple Line Versus Thoracoscopic Bullectomy Only for the Treatment of Primary Spontaneous Pneumothorax: a Single-blind, Parallel-group, Prospective, Randomized Controlled Trial
Primary spontaneous pneumothorax usually occurs in young, lean male without underlying lung disease. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the lung. Traditionally, bullectomy with mechanical pleurodesis through thoracotomy is indicated in patients with recurrence or persisted air leakage. In recent years, thoracoscopic bullectomy with pleural abrasion is getting popular, thanks for the advance of endoscopic instruments and technique. The pneumothorax recurrence rate after thoracoscopic surgery is around 10%, which is significantly higher than that of thoracotomy. In addition, the rate of postoperative prolonged air leakage is 5-8%. The possible causes of recurrent pneumothorax and prolonged air leakage are missed bleb surrounding the endoscopic suture line or suboptimal suturing or healing of the thoracoscopic suture. To prevent these complications, a novel method using coverage of the endoscopic suture line by a large absorbable mesh during thoracoscopic surgery was proved to be safe and feasible. Theoretically, the mesh can strengthen the suture line and induce local fibrosis surrounding the suture line, and reduce the rate of recurrent pneumothorax and prolonged air leakage. To prove this hypothesis, the investigators are conducting a prospective randomized trial in National Taiwan University Hospital. The investigators will enroll 204 patients with primary spontaneous pneumothorax who will be randomly assigned to additional mesh pleurodesis (mesh group, 102 patients) or not (control group, 102 patients) after thoracoscopic bullectomy and pleural abrasion. The primary endpoint is to compare the rate of pneumothorax recurrence within one year between the two groups. The secondary endpoints are to compare the safety, efficacy, and long-term pulmonary function between the two groups.
Read the detailed description
Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males (1, 2). The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax (3). Optimal management of this benign disease, especially after repeat attack, has been a matter of debate. Recent advances in video-assisted thoracoscopic surgery (VATS) that combine bullectomy with pleural abrasion provide a preferred intervention for treating primary spontaneous pneumothorax (4-6). Unfortunately, recurrence rates of pneumothorax after VATS range between 5% and 10%, which are higher than the rates reported after open thoracotomy (7-11). It is suggested that a higher chance of missed leaking blebs around the staple line of endoscopic staplers (12) and a less intense pleural inflammatory reaction are induced by VATS procedure than by thoracotomy (13, 14). In addition, postoperative air leakage usually occurs at the staple line. (7, 15) As a result, the efficacy of VATS is questioned and more aggressive procedures, such as limited thoracotomy with pleurectomy, are sometimes performed to enhance the effects of pleural symphysis (10, 14).
Theoretically, reinforcement of the visceral pleura around the staple line is a reasonable way to prevent postoperative air leak and recurrent pneumothorax. Previous retrospective studies showed that staple line coverage with absorbable mesh after thoracoscopic bullectomy is safe and may be effective in decreasing the rates of pneumothorax recurrence (16,17). One animal study also showed that when absorbable mesh insertion is coupled with pleural abrasion, appropriate pleurodesis is predictably achieved (18).
In the present study, additional absorbable mesh coverage of the staple line will be randomly administered in patients with primary spontaneous pneumothorax after VATS to test the efficacy and safety of this method.
References
- Gobbel WG Jr, Rhea WG, Nelson IA, Daniel RA Jr. Spontaneous pneumothorax. J Thorac Cardiovasc Surg 1963;46:331-345.
- Lichter J, Gwynne JF. Spontaneous pneumothorax in young subjects. Thorax 1971;25:409-417.
- Light RW. Management of spontaneous pneumothorax. Am Rev Respir Dis 1993;148:245-258.
- 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;119:590-602.
- Naunheim KS, Mack MJ, Hazelrigg SR, Ferguson MK, Ferson PF, Boley TM, Landreneau RJ. Safety and efficacy of video-assisted thoracic surgical techniques for the treatment of spontaneous pneumothorax. J Thorax Cardiovasc Surg 1995;109:1198-1204.
- Mouroux J, Elkaim D, Padovani B, Myx A, Perrin C, Rotomondo C, Chavaillon JM, Blaive B, Richelme H. Video-assisted thoracoscopic treatment of spontaneous pneumothorax: technique and results of one hundred cases. J Thorac Cardiovasc Surg 1996;112:385-391.
- Hatz 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;70:253-257.
- Inderbitzi RG, Leiser A, Furrer M, Althaus U. Three years' experience in video-assisted thoracic surgery (VATS) for spontaneous pneumothorax. J Thorac Cardiovasc Surg 1994;107:1410-1415.
- Chan P, Clarke P, Daniel FJ, Knight SR, Seevanayagam S. Efficacy study of video-assisted thoracoscopic surgery pleurodesis for spontaneous pneumothorax. Ann Thorac Surg 2001;71:452-454.
- Massard G, Thomas P, Wihlm JM. Minimally invasive management for first and recurrent pneumothorax. Ann Thorac Surg 1998;66:592-599.
- Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med 2000;342:868-874.
- Sakamoto K, Kase M, Mo M, et al. Regrowth of bullae around the staple-line is one of the causes of postoperative recurrence in thoracoscopic surgery for spontaneous pneumothorax. Kyobu Geka 1999;52:939-42.
- Gebhard FT, Becker HP, Gerngross H, Bruckner UB. Reduced inflammatory response in minimally invasive surgery of pneumothorax. Arch Surg 1996;131:1079-1082.
- Horio H, Nomori H, Fuyuno G, Naruke T, Suemasu K. Limited axillary thoracotomy vs video-assisted thoracoscopic surgery for spontaneous pneumothorax. Surg Endosc 1998:12:1155-1158.
- How CH, Tsai TM, Duo SW, et al. Chemical pleurodesis for prolonged postoperative air leak in primary spontaneous pneumothorax. J Formos Med Assoc, accepted.
- Nakanishi K. An apical symphysial technique using a wide absorbable mesh placed on the apes for primary spontaneous pneumothorax. Surg Endosc 2009;23:2515-2521.
- Sakamoto K, Takei H, Nishii T, et al. Staple line coverage with absorbable mesh after thoracoscopic bullectomy for spontaneous pneumothorax. Surg Endosc 2004;18:478-481.
- Suqarmann WM, Widmann WD, Mysh D, et al. Mesh insertion as an aid for pleurodesis. J Cardiovasc Surg 1996;37:173-5.
- Conditions
- Spontaneous Pneumothorax, Surgery
- Being tested
- Thoracoscopic bullectomy and pleural abrasion, Mesh coverage of the staple line
- Keywords
- Pneumothorax, thoracoscopy, mesh, pleurodesis, treatment
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopic bullectomy and pleural abrasionProcedure or surgery
Thoracoscopic bullectomy and pleural abrasion will be performed in a standard fashion under general anesthesia using intubated one-lung ventilation. When blebs are identified, they will be grasped with the ring forceps and excised with an endoscopic stapler. Blind apical stapling was done at the most suspicious area if no bleb could be identified. Thoracoscopic pleural abrasion will be performed at the parietal pleura above the 5th intercostal space by inserting the dissector with a strip of diathermy scratch pad through the port sites in all patients.
Mesh coverage of the staple lineBiological
Absorbable mesh coverage of the staple line will be performed in the mesh group after thoracoscopic bullectomy in the mesh group
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | In this group, only thoracoscopic bullectomy and pleural abrasion will be done. Receives: Procedure: Thoracoscopic bullectomy and pleural abrasion |
| Mesh group | Experimental | In this group, absorbable mesh coverage of the staple line will be performed after thoracoscopic bullectomy and pleural abrasion. Receives: Procedure: Thoracoscopic bullectomy and pleural abrasion; Biological: Mesh coverage of the staple line |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rates of ipsilateral pneumothorax recurrence
The detection of pneumothorax recurrence will be performed by chest radiography
Measured: 12 months
Secondary outcomes (2)
Safety of mesh coverage
Early postoperative results, including postoperative pain scores, postoperative duration of chest drainage, postoperative duration of hospital stay, and complication rates.
Measured: 30 days
long-term safety of mesh coverage
Long-term results, including residual chest pain at 6 months, and postoperative pulmonary function at 6 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (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 Spontaneous PneumothoraxStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Jin-Shing Chen, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848860
- Sponsor's protocol ID
- 201211051DIC
- Status last verified
- Jul 2015
- First submitted
- 4 May 2013
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu HH, Liu YH, Chen HY, Chen PH, Chen KC, Hsieh MJ, Lin MW, Kuo SW, Huang PM, Chao YK, Wu CF, Wu CY, Chiu CH, Chen WH, Wen CT, Liu CY, Wu YC, Chen JS. Vicryl Mesh Coverage Reduced Recurrence After Bullectomy for Primary Spontaneous Pneumothorax. Ann Thorac Surg. 2021 Nov;112(5):1609-1615. doi: 10.1016/j.athoracsur.2020.11.012. Epub 2021 May 1.
PubMed 33279544
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Bullectomy With Absorbable Mesh Coverage of the Staple Line Versus Thoracoscopic Bullectomy Only for the Treatment of Primary Spontaneous Pneumothorax: a Single-blind, Parallel-group, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01848860
- Acronym / sponsor ID
- 201211051DIC
- Conditions
- Spontaneous Pneumothorax, Surgery
- Keywords
- Pneumothorax, thoracoscopy, mesh, pleurodesis, treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung Memorial Hospital
- Study start
- May 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 May 2013 (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.
Primary spontaneous pneumothorax usually occurs in young, lean male without underlying lung disease. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the lung. Traditionally, bullectomy with mechanical pleurodesis through thoracotomy is indicated in patients with recurrence or persisted air leakage. In recent years, thoracoscopic bullectomy with pleural abrasion is getting popular, thanks for the advance of endoscopic instruments and technique. The pneumothorax recurrence rate after thoracoscopic surgery is around 10%, which is significantly higher than that of thoracotomy. In addition, the rate of postoperative prolonged air leakage is 5-8%. The possible causes of recurrent pneumothorax and prolonged air leakage are missed bleb surrounding the endoscopic suture line or suboptimal suturing or healing of the thoracoscopic suture. To prevent these complications, a novel method using coverage of the endoscopic suture line by a large absorbable mesh during thoracoscopic surgery was proved to be safe and feasible. Theoretically, the mesh can strengthen the suture line and induce local fibrosis surrounding the suture line, and reduce the rate of recurrent pneumothorax and prolonged air leakage. To prove this hypothesis, the investigators are conducting a prospective randomized trial in National Taiwan University Hospital. The investigators will enroll 204 patients with primary spontaneous pneumothorax who will be randomly assigned to additional mesh pleurodesis (mesh group, 102 patients) or not (control group, 102 patients) after thoracoscopic bullectomy and pleural abrasion. The primary endpoint is to compare the rate of pneumothorax recurrence within one year between the two groups. The secondary endpoints are to compare the safety, efficacy, and long-term pulmonary function between the two groups.
Detailed description
Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males (1, 2). The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax (3). Optimal management of this benign disease, especially after repeat attack, has been a matter of debate. Recent advances in video-assisted thoracoscopic surgery (VATS) that combine bullectomy with pleural abrasion provide a preferred intervention for treating primary spontaneous pneumothorax (4-6). Unfortunately, recurrence rates of pneumothorax after VATS range between 5% and 10%, which are higher than the rates reported after open thoracotomy (7-11). It is suggested that a higher chance of missed leaking blebs around the staple line of endoscopic staplers (12) and a less intense pleural inflammatory reaction are induced by VATS procedure than by thoracotomy (13, 14). In addition, postoperative air leakage usually occurs at the staple line. (7, 15) As a result, the efficacy of VATS is questioned and more aggressive procedures, such as limited thoracotomy with pleurectomy, are sometimes performed to enhance the effects of pleural symphysis (10, 14).
Theoretically, reinforcement of the visceral pleura around the staple line is a reasonable way to prevent postoperative air leak and recurrent pneumothorax. Previous retrospective studies showed that staple line coverage with absorbable mesh after thoracoscopic bullectomy is safe and may be effective in decreasing the rates of pneumothorax recurrence (16,17). One animal study also showed that when absorbable mesh insertion is coupled with pleural abrasion, appropriate pleurodesis is predictably achieved (18).
In the present study, additional absorbable mesh coverage of the staple line will be randomly administered in patients with primary spontaneous pneumothorax after VATS to test the efficacy and safety of this method.
References
- Gobbel WG Jr, Rhea WG, Nelson IA, Daniel RA Jr. Spontaneous pneumothorax. J Thorac Cardiovasc Surg 1963;46:331-345.
- Lichter J, Gwynne JF. Spontaneous pneumothorax in young subjects. Thorax 1971;25:409-417.
- Light RW. Management of spontaneous pneumothorax. Am Rev Respir Dis 1993;148:245-258.
- 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;119:590-602.
- Naunheim KS, Mack MJ, Hazelrigg SR, Ferguson MK, Ferson PF, Boley TM, Landreneau RJ. Safety and efficacy of video-assisted thoracic surgical techniques for the treatment of spontaneous pneumothorax. J Thorax Cardiovasc Surg 1995;109:1198-1204.
- Mouroux J, Elkaim D, Padovani B, Myx A, Perrin C, Rotomondo C, Chavaillon JM, Blaive B, Richelme H. Video-assisted thoracoscopic treatment of spontaneous pneumothorax: technique and results of one hundred cases. J Thorac Cardiovasc Surg 1996;112:385-391.
- Hatz 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;70:253-257.
- Inderbitzi RG, Leiser A, Furrer M, Althaus U. Three years' experience in video-assisted thoracic surgery (VATS) for spontaneous pneumothorax. J Thorac Cardiovasc Surg 1994;107:1410-1415.
- Chan P, Clarke P, Daniel FJ, Knight SR, Seevanayagam S. Efficacy study of video-assisted thoracoscopic surgery pleurodesis for spontaneous pneumothorax. Ann Thorac Surg 2001;71:452-454.
- Massard G, Thomas P, Wihlm JM. Minimally invasive management for first and recurrent pneumothorax. Ann Thorac Surg 1998;66:592-599.
- Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med 2000;342:868-874.
- Sakamoto K, Kase M, Mo M, et al. Regrowth of bullae around the staple-line is one of the causes of postoperative recurrence in thoracoscopic surgery for spontaneous pneumothorax. Kyobu Geka 1999;52:939-42.
- Gebhard FT, Becker HP, Gerngross H, Bruckner UB. Reduced inflammatory response in minimally invasive surgery of pneumothorax. Arch Surg 1996;131:1079-1082.
- Horio H, Nomori H, Fuyuno G, Naruke T, Suemasu K. Limited axillary thoracotomy vs video-assisted thoracoscopic surgery for spontaneous pneumothorax. Surg Endosc 1998:12:1155-1158.
- How CH, Tsai TM, Duo SW, et al. Chemical pleurodesis for prolonged postoperative air leak in primary spontaneous pneumothorax. J Formos Med Assoc, accepted.
- Nakanishi K. An apical symphysial technique using a wide absorbable mesh placed on the apes for primary spontaneous pneumothorax. Surg Endosc 2009;23:2515-2521.
- Sakamoto K, Takei H, Nishii T, et al. Staple line coverage with absorbable mesh after thoracoscopic bullectomy for spontaneous pneumothorax. Surg Endosc 2004;18:478-481.
- Suqarmann WM, Widmann WD, Mysh D, et al. Mesh insertion as an aid for pleurodesis. J Cardiovasc Surg 1996;37:173-5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Procedure: Thoracoscopic bullectomy and pleural abrasionIn this group, only thoracoscopic bullectomy and pleural abrasion will be done. |
| Mesh group | Experimental | Procedure: Thoracoscopic bullectomy and pleural abrasion, Biological: Mesh coverage of the staple lineIn this group, absorbable mesh coverage of the staple line will be performed after thoracoscopic bullectomy and pleural abrasion. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age between 15 and 50 years old.
- Spontaneous pneumothorax requiring thoracoscopic surgery.
- With written inform consent
Key exclusion criteria (12 listed)
- With underlying pulmonary disease (chronic obstructive pulmonary disease, bronchiectasis, tuberculosis, etc)
- A history of previous ipsilateral thoracic operation
- Diagnosis of catamenial pneumothorax
- Diagnosis of lymphangioleiomyomatosis
- Concurrent hemopneumothorax with bleeding > 500ml/h
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 bullectomy and pleural abrasionThoracoscopic bullectomy and pleural abrasion will be performed in a standard fashion under general anesthesia using intubated one-lung ventilation. When blebs are identified, they will be grasped with the ring forceps and excised with an endoscopic stapler. Blind apical stapling was done at the most suspicious area if no bleb could be identified. Thoracoscopic pleural abrasion will be performed at the parietal pleura above the 5th intercostal space by inserting the dissector with a strip of diathermy scratch pad through the port sites in all patients. | Procedure or surgery | Control group, Mesh group |
| Mesh coverage of the staple lineAbsorbable mesh coverage of the staple line will be performed in the mesh group after thoracoscopic bullectomy in the mesh group | Biological | Mesh group |
Primary outcome
the rates of ipsilateral pneumothorax recurrence
Time frame: 12 months
The detection of pneumothorax recurrence will be performed by chest radiography
2 secondary outcomes
Safety of mesh coverage
Time frame: 30 days
long-term safety of mesh coverage
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Derived from this study: PubMed 33279544Hsu HH, Liu YH, Chen HY, Chen PH, Chen KC, Hsieh MJ, Lin MW, Kuo SW, Huang PM, Chao YK, Wu CF, Wu CY, Chiu CH, Chen WH, Wen CT, Liu CY, Wu YC, Chen JS. Vicryl Mesh Coverage Reduced Recurrence After Bullectomy for Primary Spontaneous Pneumothorax. Ann Thorac Surg. 2021 Nov;112(5):1609-1615. doi: 10.1016/j.athoracsur.2020.11.012. Epub 2021 May 1.
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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.
Jin-Shing Chen, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Thoracoscopic bullectomy and pleural abrasion and Mesh coverage of the staple line in people with Spontaneous Pneumothorax and Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 12 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 8 Jul 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jin-Shing Chen, MD, PhD (886-972651421, chenjs@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rates of ipsilateral pneumothorax recurrence (time frame: 12 months). 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 NCT01848860, 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 8 Jul 2015.