WOPP- trial: Pulmonary wedge resection plus parietal pleurectomy (WRPP) versus parietal pleurectomy (PP) for the treatment of recurrent primary pneumothorax

WOPP 试验：肺楔形切除加壁层胸膜切除术 (WRPP) 与壁层胸膜切除术 (PP) 治疗复发性原发性气胸

• 批准号: 209750507
• 负责人: Professor Dr. Thorsten Walles
• 金额: --
• 依托单位: Klinik für Herz- und Thoraxchirurgie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2012
• 资助国家: 德国
• 起止时间: 2011-12-31 至 2023-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/209750507?language=en
• 关键词: WOPP; trial; Pulmonary; wedge; resection

Primary spontaneous pneumothoraces (PSP) represent a significant public health problem, occurring healthy subjects aged under 40 without pre-existing lung disease or precedent medical intervention or trauma. Incidence is 18–28/100 000 per year. The pathomechanism of pulmonary fistula formation resulting in lung collapse is not understood so far. While first-time PSP may be treated successfully by tube-thoracotomy only. Recurrent disease is recommended to be treated by thoracic surgery to restore lung expansion and to prevent de novo lung collapse. Different surgical approaches with varying aggressiveness are inconsistently applied by thoracic surgeons on the basis of lacking evidence-based data. In Germany, both apical wedge resection of the lung and total parietal pleurectomy (WRPP) and the cost-saving partial apical parietal pleurectomy (PP) are established surgical procedures to treat recurrent PSP. In Europe, two clinical practice guidelines published by the British Thoracic Society and several German medical societies in 2010 and 2018, respectively, were not able to assess the significance of lung resection in the course of surgical treatment. In 2013, the investigator-initiated randomized, multi-centric WOPP-trial got off the ground to compare both treatment approaches (NCT01855464)(www.wopp-studie.de). The study randomizes candidates for surgery into one of the two treatment groups after informed consent has been obtained. Patients are followed for 2 years by the participating centers to be able to evaluate the long-term effect of the surgical interventions.

原发性自发性气胸（PSP）是一个重大的公共卫生问题，发生在40岁以下的健康受试者，没有先前存在的肺部疾病或既往的医疗干预或创伤。发病率为每年18 - 28/10万。肺瘘形成导致肺萎陷的病理机制目前尚不清楚。而首次发生的PSP仅通过开胸管即可成功治疗。复发性疾病建议胸外科手术治疗，以恢复肺扩张，防止新发肺萎陷。胸外科医生在缺乏循证数据的基础上，不一致地应用不同侵袭性的不同手术入路。在德国，肺根尖楔形切除术和全胸膜顶骨切除术（WRPP）以及成本较低的部分胸膜顶骨切除术（PP）都是治疗复发性PSP的手术方法。在欧洲，分别于2010年和2018年由英国胸科学会和几个德国医学学会发布的两份临床实践指南无法评估肺切除术在手术治疗过程中的意义。2013年，研究者发起的随机多中心wopp试验开始比较两种治疗方法（NCT01855464）（www.wopp-studie.de）。在获得知情同意后，研究将手术候选人随机分为两个治疗组之一。参与中心对患者进行为期2年的随访，以评估手术干预的长期效果。