Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax: A Randomized Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- to compare the rates of ipsilateral recurrence between the minocycline and observation groups after simple aspiration of the pneumothorax.
研究概览
简要总结
The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care.
Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration to test if it can reduce the rate of recurrence.
详细描述
Background:
Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males (1, 2). The estimated recurrence rate is 23-50% after the first episode (3). Optimal treatment of patients presenting with a first episode of primary spontaneous pneumothorax remains unknown. In the recently published British Thoracic Society (BTS) guidelines (4), simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 26-30% (5), making it inappropriate as a standard of care.
Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients (6, 7). Light et al. has shown that intrapleural tetracycline is effective in reducing the rate of ipsilateral recurrence for patients with spontaneous pneumothorax (7). However, the recently published guidelines recommended that chemical pleurodesis should only be attempted if the patient is either unwilling or unable to undergo surgery because the rates of recurrence of pneumothoraces after surgical intervention either by thoracotomy or VATS, with or without surgical pleurodesis, is far less than after chemical pleurodesis (4, 8). As a result, chemical pleurodesis has rarely been used in primary spontaneous pneumothorax, and the effect of additional chemical pleurodesis after simple aspiration in preventing recurrence of pneumothoraces has never been evaluated.
Tetracycline, which was the most commonly used irritant, is no longer available. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits (9). In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure that associates with lower rates of prolonged air leaks and ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax (10, 11).
In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration to test if it can reduce the rate of recurrence. This study will comply with the protocol, GCP and applicable requirement of the Institutional Review Boards (IRB) of the NTUH and Far Eastern Memorial Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •Age between 15 and 40 years old.
- •First episode of spontaneous pneumothorax.
- •Symptomatic (dyspnea or chest pain) or the rim of air is > 2cm on CXR requiring simple aspiration
- •Complete or nearly complete and persistent lung expansion immediately following manual aspiration
- •Organ Function Requirements:
- •Adequate hematological function (Hb > 10 g/dl, ANC > 1.5 x 109/L, platelets > 100 x 109/L)
- •Normal renal and hepatic functions: serum creatinine < 1 x ULN, SGPT and SGOT< 2.5 x ULN, alkaline phosphatase < 5 x ULN
- •Written inform consent
排除标准
- •With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc)
- •With hemothorax or tension pneumothorax requiring chest tube insertion or operation
- •A history of previous pneumothorax
- •A history of previous ipsilateral thoracic operation
- •Allergy to tetracycline or minocycline
- •Pregnant or lactating patients.
- •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.
结局指标
主要结局
to compare the rates of ipsilateral recurrence between the minocycline and observation groups after simple aspiration of the pneumothorax.
时间窗: 12 months after treatment
次要结局
- Safety profile of minocycline pleurodesis(12 months after treatment)
- Early results, including immediate success rates, one-week success rates, complication rates, rates of hospitalization, duration of hospitalization, and the degrees of chest pain.(7 days after treatment)
- Long-term effects of minocycline pleurodesis, including degrees of residual chest pain and pulmonary function test(12 months after treatment)