Randomized, Multicenter, Non-inferiority Clinical Trial to Design a Conservative Strategy for the Treatment of Primary Spontaneous Pneumothorax (PSP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 436
- 主要终点
- Complete lung re-expansion on chest X-ray
研究概览
简要总结
The goal of this randomized clinical trial is to find out whether a conservative management strategy (active observation without an initial invasive procedure) can treat as effectively as the standard treatment with chest tube drainage in adults with a large primary spontaneous pneumothorax who are clinically stable. Participants include men and women 18 to 60 years old with a lung collapse ≥30% (by Collins method).
The main questions are:
- Is conservative management not inferior to chest tube drainage for achieving complete lung re-expansion at 8 weeks (on chest X-ray)?
- What are the differences between the two strategies in complications, recurrence at 2 years, quality of life, length of hospital stay, number of additional procedures, and healthcare costs?
Comparison groups:
- Conservative management: in-hospital observation with a control chest X-ray no earlier than 4 hours; if the person remains stable, discharge home with scheduled outpatient follow-up and serial X-rays until resolution.
- Standard treatment (chest tube): chest tube placement and hospital admission; discharge based on clinical progress with routine outpatient follow-up.
Researchers will compare both groups to see whether conservative management works just as well to resolve the pneumothorax at 8 weeks and whether it leads to fewer complications, shorter hospital stays, better quality of life, and lower costs.
What will participants be asked to do? Review the participant information sheet and sign informed consent.
Be randomized by computer (REDCap) to either conservative management or chest tube drainage.
Depending on the assigned group:
- Conservative group: remain under observation initially, have a chest X-ray at ≥4 hours; if still stable, go home with clinic visits (about 1 week after discharge and then every ~2 weeks) until the pneumothorax has resolved.
- Chest tube group: undergo chest tube insertion, stay in the hospital, and attend routine outpatient follow-up after discharge.
Undergo chest X-rays interpreted by the clinical team (with centralized review procedures).
Complete brief symptom assessments, quality-of-life questionnaires (e.g., EQ-5D-5L), and attend follow-up visits or phone calls for up to 2 years to check for recurrences.
This is a multicenter study conducted in several hospitals in Spain. The planned sample size is 436 participants (218 per group), with a non-inferiority margin of 5% and the primary assessment at 8 weeks.
详细描述
Background and Rationale
Primary spontaneous pneumothorax (PSP) commonly affects young, otherwise healthy individuals. Large PSP has traditionally been managed with chest tube drainage and hospital admission, which can cause pain, longer stays, and procedure-related complications. Emerging evidence and guideline trends suggest that, in clinically stable, minimally symptomatic patients, a conservative strategy (no immediate invasive procedure) may be as effective as invasive options while reducing complications and improving patient experience. However, the current evidence base remains limited, justifying a multicenter randomized trial to rigorously compare both strategies.
This protocol uses the Collins method on chest radiography to estimate pneumothorax size because it correlates with CT-based estimates and is practical for routine care.
Primary Objective
To demonstrate the non-inferiority of conservative management compared with chest tube drainage in achieving complete lung re-expansion at 8 weeks, defined as no pleural air on chest X-ray.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: >18 and ≤60 years at the time of enrollment.
- •Diagnosis: Primary spontaneous pneumothorax of large size (lung collapse ≥30% by the Collins method on chest X-ray).
- •Episode type: Any episode of primary spontaneous pneumothorax.
- •Clinical stability suitable for observation without immediate intervention: Systolic BP >90 mmHg, heart rate <140 bpm, oxygen saturation >90% (with supplemental oxygen if needed), respiratory rate 15-30 breaths/min.
- •Consent: Has read and understood the participant information sheet and signed informed consent.
排除标准
- •Pre-existing lung disease that may predispose to pneumothorax (e.g., COPD, cystic fibrosis, interstitial lung disease, tuberculosis, pulmonary neoplasm).
- •Indication for urgent thoracic surgery (e.g., imaging highly suggestive of giant bullae/blebs requiring immediate surgical intervention).
- •Pregnancy or breastfeeding.
结局指标
主要结局
Complete lung re-expansion on chest X-ray
时间窗: 8 weeks after randomization.
Proportion of participants with no pleural air on the 8-week chest X-ray (definition of complete radiographic resolution).
Complete lung re-expansion on chest X-ray
时间窗: 8 weeks after randomization.
Proportion of participants with no pleural air on the 8-week chest X-ray (definition of complete radiographic resolution).
次要结局
- Health-Related Quality of Life Assessed by EQ-5D-5L(Up to 24 weeks)
- Health-Related Quality of Life Assessed by EQ-5D-5L(Up to 24 weeks)
- Treatment-related complications(Procedure- or management-related adverse events (e.g., bleeding, infection, persistent air leak, need for reintervention or surgery), prospectively recorded.)
- Recurrence of pneumothorax.(Up to 2 years after resolution of the index episode.)
研究者
Carlos Molero-Cano
Residente de Cirugía General y del Aparato Digestivo
Corporacion Parc Tauli