DICE试验研究方案：电视辅助胸腔镜手术纤维板剥脱术与介入放射学引导下胸腔置管术治疗脓胸的对比研究
Study protocol for DICE trial: Video-assisted thoracoscopic surgery decortication versus interventional radiology guided chest tube insertion for the management of empyema.
作者信息
Williams Erin, Hanna Nader, Menard Alex, Mussari Benedetto, Nasirzadeh Reza, Tarulli Emidio, Dhillon Gurmohan Rob, Reid Ken, Petsikas Dimitri, Pereira Jennifer, Heffernan Paul, Chung Wiley
机构信息
Division of Thoracic Surgery, Department of Surgery, Queen's University, 76 Stuart Street, Kingston, ON, K7L 2V7, Canada.
Division of Interventional Radiology, Department of Radiology, Queen's University, 76 Stuart Street, Kingston, ON, K7L 2V7, Canada.
出版信息
Contemp Clin Trials Commun. 2021 Apr 15;22:100777. doi: 10.1016/j.conctc.2021.100777. eCollection 2021 Jun.
BACKGROUND
Empyema is a common thoracic surgery presentation, defined as pus in the pleural space. Despite the commonality of empyema, consensus on initial management remains ambiguous. Two standard of care treatment options include inserting a chest tube (thoracostomy) and the administration of intrapleural fibrinolytics, or an initial surgical approach, surgical decortication. Due to the complexity of this pleural space infection, often repeat interventions are required after initial management in order to achieve source control and resolution of clinical symptoms. This study aims to identify the most effective initial management option for empyema.
STUDY DESIGN
We present a study protocol for a randomized control trial (RCT) comparing adult individuals with empyema to one of two standard of care initial management options. Participants will be randomized into either interventional radiology guided chest tube insertion with intrapleural fibrinolytics (Dornase 5 mg and Alteplase 10 mg intrapleural twice daily for three days) or video-assisted thoracoscopic surgery (VATS) decortication.
METHODS
All adults with empyema meeting inclusion criteria will be invited to participate. They will be randomized into one of two intervention groups; interventional radiology guided chest tube insertion with fibrinolytics or initial VATS decortication. Each intervention will take place within 48 hours of randomization. The primary outcome will be the rate of re-intervention within 30 days. Re-intervention is defined as repeat chest tube insertion, VATS decortication, or decortication via thoracotomy. Secondary outcomes include a change in the size of empyema, length of stay, morbidity, as well as 30-day and 90-day mortality, as well as quality of life measurements.
ANTICIPATED IMPACT
This study is aimed at identifying the most effective initial management option for individuals with empyema.
背景
脓胸是胸外科常见的病症，定义为胸膜腔内有脓液。尽管脓胸很常见，但对于初始治疗的共识仍不明确。两种标准治疗方案包括插入胸管（胸廓造口术）并给予胸膜腔内纤维蛋白溶解剂，或采用初始手术方法，即手术剥脱术。由于这种胸膜腔感染的复杂性，初始治疗后通常需要重复干预，以实现源头控制并缓解临床症状。本研究旨在确定脓胸最有效的初始治疗方案。
研究设计
我们提出一项随机对照试验（RCT）的研究方案，将患有脓胸的成年人与两种标准初始治疗方案之一进行比较。参与者将被随机分为介入放射学引导下胸管插入并给予胸膜腔内纤维蛋白溶解剂（ Dornase 5毫克和阿替普酶10毫克，胸膜腔内每日两次，共三天）或电视辅助胸腔镜手术（VATS）剥脱术。
方法
所有符合纳入标准的成年脓胸患者将被邀请参与。他们将被随机分为两个干预组之一；介入放射学引导下胸管插入并使用纤维蛋白溶解剂或初始VATS剥脱术。每次干预将在随机分组后48小时内进行。主要结局将是30天内再次干预的发生率。再次干预定义为重复胸管插入、VATS剥脱术或开胸剥脱术。次要结局包括脓胸大小的变化、住院时间、发病率、30天和90天死亡率，以及生活质量测量。
预期影响
本研究旨在确定脓胸患者最有效的初始治疗方案。
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