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| Name | Class |
|---|---|
| Department of Health, Executive Yuan, R.O.C. (Taiwan) | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Surgery: Video-assisted thoracoscopic surgery |
|
| 2 | Active Comparator | Chest tube drainage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video-assisted thoracoscopic surgery | Procedure | VATS for bullectomy and mechanical pleurodesis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the number of days in hospital, after intervention, of each group. | within one month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within one month | |
| Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin-Shing Chen, MD.,PhD | Contact | 886-2-23123456 | 65178 | chenjs@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yung-Chie Lee, MD, PhD | National Taiwan University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
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| chest tube drainage |
| Procedure |
Chest tube drainage for pneumothroax |
|
| 2 years |
| Total costs of each patients in assigned treatment. | 2 years |
| Far Eastern Memorial Hospital | Recruiting | Taipei County | Taiwan |
|
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |