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Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax

Primary Purpose

Pneumothorax

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Video-assisted thoracoscopic surgery
chest tube drainage
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring Aspiration, chest tube, pneumothorax, thoracoscopic surgery

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 15 and 50 years old.
  2. First episode of spontaneous pneumothorax.
  3. The rim of air is > 2cm on CXR requiring simple aspiration
  4. Aspiration as the initial treatment
  5. Failed to achieve lung expansion following repeat manual aspiration

Exclusion Criteria:

  1. Complete or nearly complete and persistent lung expansion immediately following manual aspiration
  2. With underlying pulmonary disease (TB, asthma, etc)
  3. With hemothorax or tension pneumothorax requiring chest tube insertion or operation
  4. A history of previous pneumothorax
  5. A history of previous ipsilateral thoracic operation
  6. Pregnant or lactation female

Sites / Locations

  • Far Eastern Memorial HospitalRecruiting
  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Surgery: Video-assisted thoracoscopic surgery

Chest tube drainage

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment
Total costs of each patients in assigned treatment.

Full Information

First Posted
July 9, 2008
Last Updated
December 13, 2012
Sponsor
National Taiwan University Hospital
Collaborators
Department of Health, Executive Yuan, R.O.C. (Taiwan)
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1. Study Identification

Unique Protocol Identification Number
NCT00713362
Brief Title
Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax
Official Title
Comparison of Chest Tube Drainage Versus Thoracoscopic Surgery for Unsuccessful Aspiration of Primary Spontaneous Pneumothorax: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Department of Health, Executive Yuan, R.O.C. (Taiwan)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
Aspiration, chest tube, pneumothorax, thoracoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Surgery: Video-assisted thoracoscopic surgery
Arm Title
2
Arm Type
Active Comparator
Arm Description
Chest tube drainage
Intervention Type
Procedure
Intervention Name(s)
Video-assisted thoracoscopic surgery
Intervention Description
VATS for bullectomy and mechanical pleurodesis
Intervention Type
Procedure
Intervention Name(s)
chest tube drainage
Intervention Description
Chest tube drainage for pneumothroax
Primary Outcome Measure Information:
Title
Comparing the number of days in hospital, after intervention, of each group.
Time Frame
within one month
Secondary Outcome Measure Information:
Title
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
Title
Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment
Time Frame
2 years
Title
Total costs of each patients in assigned treatment.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Shing Chen, MD.,PhD
Phone
886-2-23123456
Ext
65178
Email
chenjs@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Chie Lee, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei county
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kung-Tsao Tsai, MD
Phone
886-917925017
Email
hikali888@gmail.com
First Name & Middle Initial & Last Name & Degree
Kung-Tsao Tsai, MD
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
Phone
886-2-23123456
Ext
5178
Email
chenjs@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax

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