Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Time to ipsilateral recurrence
研究概览
简要总结
Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.The Aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic predispositions.
详细描述
- Background Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial. Typically, the first incidence is treated conservatively with simple chest tube drainage and only if the disease reoccurs is surgery considered. However, conventional treatment may be associated with increased morbidity, prolonged hospitalization and many young adults are concerned about the high recurrence of this disease. The latter has been reported in as many as 25-35% of patients. Because spontaneous pneumothorax in young adults usually is associated with apical blebs, the investigators hypothesized that primary surgery (Video-Assisted Thoracoscopic Surgery = VATS) with resection of such blebs at the time of the first episode of pneumothorax might be an effective first line treatment associated with lower morbidity and shorter hospital stays, and a definite decline in recurrence rate.
- Method From July 2009 the investigators conducted a nationwide study , where 300 consecutive patients admitted to a Danish hospital with primary spontaneous pneumothorax undergo a high resolution CT of the thorax. Based upon the CT the patients are randomised to conventional conservative treatment (chest tube drainage) or primary VATS with bleb resection and mechanical pleurodesis.
Participants are followed for ten years. The primary endpoint is ipsilateral recurrence of pneumothorax. Secondary endpoints are length of hospitalization, duration of chest tube drainage and miscellaneous complications.
Simultaneously, a research biobank containing blood samples and pulmonary tissue is created for future studies of biomarkers and possible genetic causes.
Finally, the investigators are conducting a national epidemiological study, where the incidence in the Danish population is investigated.
*Perspective This study contributes new knowledge on incidence, genetics and best treatment of primary spontaneous pneumothorax in young adults which will have an impact on the future strategy of both understanding and treatment of this disease on a global level.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First incidence of primary spontaneous pneumothorax.
- •Age between 18 and
- •No known preexisting pulmonary disease.
- •Patient must accept randomization.
- •Able to read and understand information regarding the study.
- •The condition must require treatment with a chest-tube.
排除标准
- •Age above
- •Previously pulmonary og cardiac surgery.
- •Pregnant or breastfeeding.
- •Patients who do not tolerate anesthetics.
研究组 & 干预措施
HRCT no bullae, treatment conservative
Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage.
干预措施: High-resolution Computer Tomography (Radiation)
HRCT with bullae, treatment conservative
Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage.
干预措施: Chest tube insertion (Procedure)
HRCT with bullae, treatment conservative
Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage.
干预措施: High-resolution Computer Tomography (Radiation)
HRCT no bullae, treatment conservative
Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage.
干预措施: Chest tube insertion (Procedure)
HRCT with bullae, treatment VATS.
Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.
干预措施: VATS bullectomy and mechanical pleuradesis. (Procedure)
HRCT with bullae, treatment VATS.
Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.
干预措施: Chest tube insertion (Procedure)
HRCT with bullae, treatment VATS.
Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.
干预措施: Epidural (Drug)
HRCT with bullae, treatment VATS.
Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.
干预措施: High-resolution Computer Tomography (Radiation)
HRCT no bullae, treatment VATS.
Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.
干预措施: VATS bullectomy and mechanical pleuradesis. (Procedure)
HRCT no bullae, treatment VATS.
Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.
干预措施: Chest tube insertion (Procedure)
HRCT no bullae, treatment VATS.
Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.
干预措施: Epidural (Drug)
HRCT no bullae, treatment VATS.
Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis.
干预措施: High-resolution Computer Tomography (Radiation)
结局指标
主要结局
Time to ipsilateral recurrence
时间窗: 10 years
All participants are followed 10 years from the initial discharge via Questionnaires
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(10 years)
- Length of hospital stay(up to 10 years)
- Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years.(up to 10 years)
研究者
Winnie Hedevang Olesen
MD and Principal investigator
Odense University Hospital