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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Jin-Shing Chen, MD.,PhD contact

886-2-23123456 ext. 65178

chenjs@ntu.edu.tw

Taiwan2 sites, 2 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

    Recruiting

Other trials in Taiwan

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:

  1. Gobbel WG Jr, Rhea WG, Nelson IA, Daniel RA Jr. Spontaneous pneumothorax. J Thorac Cardiovasc Surg 1963;46:331-45.
  2. Lichter J, Gwynne JF. Spontaneous pneumothorax in young subjects. Thorax 1971;25:409-17.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Ng AW, Chan KW, Lee SK. Simple aspiration of pneumothorax. Singapore Med J 1994;35:50-2.
  9. Markos J, McConigle P, Phillips MJ. Pneumothorax: treatment by small-lumen catheter aspiration. Aust NZ J Med 1990;20:775-81.
  10. 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.
  11. 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.
  12. Ayed AK, Chandrasekaran C, Sukumar M. Aspiration versus tube drainage in primary spontaneous pneumothorax: a randomized study. Eur Respir J 2006;27:477-82.
  13. 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.
  14. 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.
  15. 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.
  16. 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 groups in NCT00713362
Study groupRoleWhat they receive
1Active comparatorSurgery: Video-assisted thoracoscopic surgery
Receives: Procedure: Video-assisted thoracoscopic surgery
2Active comparatorChest tube drainage
Receives: Procedure: chest tube drainage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparing the number of days in hospital, after intervention, of each group.

    Measured: within one month

Secondary outcomes (3)
  1. 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

  2. Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment

    Measured: 2 years

  3. 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.

  1. First posted11 Jul 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionNov 2012
  4. Study completionSep 2013 (estimated)

Resources

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)
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

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.

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