PneumothoraxPhase 2/3NCT00713362
Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax
A Phase 2/3 study testing Video-assisted thoracoscopic surgery and chest tube drainage in people with Pneumothorax, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
We hypothesize that VATS is more effective than CTD for management of primary spontaneous pneumothorax with aspiration failure. To this end, we will compare two groups of patients who had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by treatment. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Video-assisted thoracoscopic surgery and chest tube drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- Apr 2008to Sep 2013
- 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.
- First episode of spontaneous pneumothorax.
- The rim of air is > 2cm on CXR requiring simple aspiration
- Aspiration as the initial treatment
- Failed to achieve lung expansion following repeat manual aspiration
Who cannot join
- Complete or nearly complete and persistent lung expansion immediately following manual aspiration
- With underlying pulmonary disease (TB, asthma, etc)
- With hemothorax or tension pneumothorax requiring chest tube insertion or operation
- A history of previous pneumothorax
- A history of previous ipsilateral thoracic operation
- Pregnant or lactation female
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jin-Shing Chen, MD, PhD, 886-2-23123456 ext. 5178, chenjs@ntu.edu.tw
Jin-Shing Chen, MD, PhD
- Recruiting
Far Eastern Memorial Hospital
Taipei County
Kung-Tsao Tsai, MD, 886-917925017, hikali888@gmail.com
Kung-Tsao Tsai, MD
About this study
Official title: Comparison of Chest Tube Drainage Versus Thoracoscopic Surgery for Unsuccessful Aspiration of Primary Spontaneous Pneumothorax: a Prospective Randomized Trial
We hypothesize that VATS is more effective than CTD for management of primary spontaneous pneumothorax with aspiration failure. To this end, we will compare two groups of patients who had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by treatment.
Read the detailed description
Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males [1, 2]. Optimal management for a first episode of this benign disease has been a matter of debate. In the recently published BTS guidelines [3], simple aspiration is recommended as the first-line treatment for all primary pneumothoraces requiring intervention because it appears to be as effective as chest tube drainage (CTD), as well as safe, well tolerated and feasible in an outpatient setting in the majority of cases [3]. When simple aspiration was unsuccessful, which occurred in about 15-62% of all pneumothoraces requiring intervention, chest tube drainage is recommended [3-12]. However, many prospective studies that have compared simple aspiration and tube drainage for primary spontaneous pneumothorax have shown that they are equally effective for treatment of primary spontaneous pneumothorax in terms of success and recurrence rates [4, 11, 12]. In this regard, chest tube drainage provides no benefits in unsuccessful aspiration of primary spontaneous pneumothorax because the rates of persistent air leakage and recurrence remain the same.
Advances in video-assisted thoracoscopic surgery (VATS) have made it a safe, less-invasive and more-effective intervention for treating recurrent pneumothorax or persistent air leakage after CTD [13-15]. However, the role of VATS in the management of first primary spontaneous pneumothorax where aspiration has failed remains unclear. Theoretically, unsuccessful aspiration is usually associated with large or persistent air leaks. Definitive treatment would include elimination of air leakage and, if possible, recurrence. Under such consideration, VATS with bullectomy and mechanical pleurodesis provides a good alternative in terms of achieving these therapeutic goals. We hypothesize that VATS is more effective than CTD for management of primary spontaneous pneumothorax with aspiration failure. To this end, we will compare two groups of patients who had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by treatment.
This study will be performed at National Taiwan University Hospital (40 patients), Far-Eastern Memorial Hospital (10 patients), and Min-Sheng General Hospital (10 patients). A total of 60 patients will be included (30 patients in each arm).
References:
- Gobbel WG Jr, Rhea WG, Nelson IA, Daniel RA Jr. Spontaneous pneumothorax. J Thorac Cardiovasc Surg 1963;46:331-45.
- Lichter J, Gwynne JF. Spontaneous pneumothorax in young subjects. Thorax 1971;25:409-17.
- Henry M, Arnold T, Harvey J. Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax 2003;58 (Suppl 2):39-52.
- Harvey J, Prescott RJ. Simple aspiration versus intercostal tube drainage for spontaneous pneumothorax in patients with normal lungs. British Thoracic Society Research Committee. BMJ 1994;309:1338-9.
- Packham S, Jaiswal P. Spontaneous pneumothorax: use of aspiration and outcomes of management by respiratory and general physicians. Postgrad Med J 2003;79:345-7.
- Chan SS, Lam PK. Simple aspiration as initial treatment for primary spontaneous pneumothorax: Results of 91 consecutive cases. J Emerg Med 2005;28:133-8.
- Mendis D, El-Shanawany T, Mathur A, Redington AE. Management of spontaneous pneumothorax: are British Thoracic Society guidelines being followed? Postgrad Med J 2002;78:80-4.
- Ng AW, Chan KW, Lee SK. Simple aspiration of pneumothorax. Singapore Med J 1994;35:50-2.
- Markos J, McConigle P, Phillips MJ. Pneumothorax: treatment by small-lumen catheter aspiration. Aust NZ J Med 1990;20:775-81.
- Andrivet P, Djedaini K, Teboul JL, Brochard L, Dreyfuss D. Spontaneous pneumothorax. Comparison of thoracic drainage vs immediate or delayed needle aspiration. Chest 1995;108:335-40.
- Noppen M, Alexander P, Driesen P, Slabbynck H, Verstraeten A. Manual aspiration versus chest tube drainage in first episodes of primary spontaneous pneumothorax: a multicenter, prospective, randomized pilot study. Am J Respir Crit Care Med 2002;165:1240-4.
- Ayed AK, Chandrasekaran C, Sukumar M. Aspiration versus tube drainage in primary spontaneous pneumothorax: a randomized study. Eur Respir J 2006;27:477-82.
- 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 Thorac Cardiovasc Surg 1995;109:1198-204.
- 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;112:385-91.
- Chen JS, Hsu, HH, Kuo SW, Tsai PR, Chen RJ, Lee JM, Lee YC. Needlescopic versus conventional video-assisted thoracoscopic surgery for primary spontaneous pneumothorax: a comparative study. Ann Thorac Surg 2003;75:1080-5.
- Conditions
- Pneumothorax
- Being tested
- Video-assisted thoracoscopic surgery, chest tube drainage
- Keywords
- Aspiration, chest tube, pneumothorax, thoracoscopic surgery
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted thoracoscopic surgeryProcedure or surgery
VATS for bullectomy and mechanical pleurodesis
chest tube drainageProcedure or surgery
Chest tube drainage for pneumothroax
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Surgery: Video-assisted thoracoscopic surgery Receives: Procedure: Video-assisted thoracoscopic surgery |
| 2 | Active comparator | Chest tube drainage Receives: Procedure: chest tube drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the number of days in hospital, after intervention, of each group.
Measured: within one month
Secondary outcomes (3)
Short-term outcome, including number of days with chest drainage, total hospital stay, short-term failure rate of assigned treatment, adverse events, pain score, mean dose of meperidine requested.
Measured: within one month
Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment
Measured: 2 years
Total costs of each patients in assigned treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2012
- Study completionSep 2013 (estimated)
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 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Responsible party
- Sponsor
- Investigators
- Yung-Chie Lee, MD, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713362
- Sponsor's protocol ID
- 200801030R
- Status last verified
- Nov 2012
- First submitted
- 9 Jul 2008
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Chest Tube Drainage Versus Thoracoscopic Surgery for Unsuccessful Aspiration of Primary Spontaneous Pneumothorax: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00713362
- Acronym / sponsor ID
- 200801030R
- Conditions
- Pneumothorax
- Keywords
- Aspiration, chest tube, pneumothorax, thoracoscopic surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- Apr 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 11 Jul 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.
We hypothesize that VATS is more effective than CTD for management of primary spontaneous pneumothorax with aspiration failure. To this end, we will compare two groups of patients who had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by treatment.
Detailed description
Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males [1, 2]. Optimal management for a first episode of this benign disease has been a matter of debate. In the recently published BTS guidelines [3], simple aspiration is recommended as the first-line treatment for all primary pneumothoraces requiring intervention because it appears to be as effective as chest tube drainage (CTD), as well as safe, well tolerated and feasible in an outpatient setting in the majority of cases [3]. When simple aspiration was unsuccessful, which occurred in about 15-62% of all pneumothoraces requiring intervention, chest tube drainage is recommended [3-12]. However, many prospective studies that have compared simple aspiration and tube drainage for primary spontaneous pneumothorax have shown that they are equally effective for treatment of primary spontaneous pneumothorax in terms of success and recurrence rates [4, 11, 12]. In this regard, chest tube drainage provides no benefits in unsuccessful aspiration of primary spontaneous pneumothorax because the rates of persistent air leakage and recurrence remain the same.
Advances in video-assisted thoracoscopic surgery (VATS) have made it a safe, less-invasive and more-effective intervention for treating recurrent pneumothorax or persistent air leakage after CTD [13-15]. However, the role of VATS in the management of first primary spontaneous pneumothorax where aspiration has failed remains unclear. Theoretically, unsuccessful aspiration is usually associated with large or persistent air leaks. Definitive treatment would include elimination of air leakage and, if possible, recurrence. Under such consideration, VATS with bullectomy and mechanical pleurodesis provides a good alternative in terms of achieving these therapeutic goals. We hypothesize that VATS is more effective than CTD for management of primary spontaneous pneumothorax with aspiration failure. To this end, we will compare two groups of patients who had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by treatment.
This study will be performed at National Taiwan University Hospital (40 patients), Far-Eastern Memorial Hospital (10 patients), and Min-Sheng General Hospital (10 patients). A total of 60 patients will be included (30 patients in each arm).
References:
- Gobbel WG Jr, Rhea WG, Nelson IA, Daniel RA Jr. Spontaneous pneumothorax. J Thorac Cardiovasc Surg 1963;46:331-45.
- Lichter J, Gwynne JF. Spontaneous pneumothorax in young subjects. Thorax 1971;25:409-17.
- Henry M, Arnold T, Harvey J. Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax 2003;58 (Suppl 2):39-52.
- Harvey J, Prescott RJ. Simple aspiration versus intercostal tube drainage for spontaneous pneumothorax in patients with normal lungs. British Thoracic Society Research Committee. BMJ 1994;309:1338-9.
- Packham S, Jaiswal P. Spontaneous pneumothorax: use of aspiration and outcomes of management by respiratory and general physicians. Postgrad Med J 2003;79:345-7.
- Chan SS, Lam PK. Simple aspiration as initial treatment for primary spontaneous pneumothorax: Results of 91 consecutive cases. J Emerg Med 2005;28:133-8.
- Mendis D, El-Shanawany T, Mathur A, Redington AE. Management of spontaneous pneumothorax: are British Thoracic Society guidelines being followed? Postgrad Med J 2002;78:80-4.
- Ng AW, Chan KW, Lee SK. Simple aspiration of pneumothorax. Singapore Med J 1994;35:50-2.
- Markos J, McConigle P, Phillips MJ. Pneumothorax: treatment by small-lumen catheter aspiration. Aust NZ J Med 1990;20:775-81.
- Andrivet P, Djedaini K, Teboul JL, Brochard L, Dreyfuss D. Spontaneous pneumothorax. Comparison of thoracic drainage vs immediate or delayed needle aspiration. Chest 1995;108:335-40.
- Noppen M, Alexander P, Driesen P, Slabbynck H, Verstraeten A. Manual aspiration versus chest tube drainage in first episodes of primary spontaneous pneumothorax: a multicenter, prospective, randomized pilot study. Am J Respir Crit Care Med 2002;165:1240-4.
- Ayed AK, Chandrasekaran C, Sukumar M. Aspiration versus tube drainage in primary spontaneous pneumothorax: a randomized study. Eur Respir J 2006;27:477-82.
- 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 Thorac Cardiovasc Surg 1995;109:1198-204.
- 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;112:385-91.
- Chen JS, Hsu, HH, Kuo SW, Tsai PR, Chen RJ, Lee JM, Lee YC. Needlescopic versus conventional video-assisted thoracoscopic surgery for primary spontaneous pneumothorax: a comparative study. Ann Thorac Surg 2003;75:1080-5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Video-assisted thoracoscopic surgerySurgery: Video-assisted thoracoscopic surgery |
| 2 | Active comparator | Procedure: chest tube drainageChest tube drainage |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 15 and 50 years old.
- First episode of spontaneous pneumothorax.
- The rim of air is > 2cm on CXR requiring simple aspiration
- Aspiration as the initial treatment
- Failed to achieve lung expansion following repeat manual aspiration
Key exclusion criteria (6 listed)
- Complete or nearly complete and persistent lung expansion immediately following manual aspiration
- With underlying pulmonary disease (TB, asthma, etc)
- With hemothorax or tension pneumothorax requiring chest tube insertion or operation
- A history of previous pneumothorax
- A history of previous ipsilateral thoracic operation
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 |
|---|---|---|
| Video-assisted thoracoscopic surgeryVATS for bullectomy and mechanical pleurodesis | Procedure or surgery | 1 |
| chest tube drainageChest tube drainage for pneumothroax | Procedure or surgery | 2 |
Primary outcome
Comparing the number of days in hospital, after intervention, of each group.
Time frame: within one month
3 secondary outcomes
Short-term outcome, including number of days with chest drainage, total hospital stay, short-term failure rate of assigned treatment, adverse events, pain score, mean dose of meperidine requested.
Time frame: within one month
Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment
Time frame: 2 years
Total costs of each patients in assigned treatment.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Yung-Chie Lee, MD, PhD study chair
National Taiwan University Hospital
2 sites 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 Video-assisted thoracoscopic surgery and chest tube drainage in people with Pneumothorax, run by National Taiwan University Hospital at 2 sites 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 5 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 (886-2-23123456 ext. 65178, chenjs@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the number of days in hospital, after intervention, of each group. (time frame: within one month). 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 17 Dec 2012.