Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan,
Eur Surg Res. 2020;61(4-5):123-129. doi: 10.1159/000506512. Epub 2020 Apr 3.
Pneumonia is one of the most frequently occurring complications after esophagectomy and is associated with increased operative mortality. Chronic obstructive pulmonary disease (COPD) is known to be a risk factor for pulmonary complications and operative mortality. However, in COPD patients preparing for esophagectomy, preventive measures against postoperative pneumonia have not yet been discovered. In this study, we evaluate the effect of perioperative inhaled tiotropium, a long-acting, antimuscarinic bronchodilator used in the management of COPD, on patients with COPD who undergo esophageal cancer surgery.
METHODS/DESIGN: This study investigates the effect of perioperative inhaled tiotropium on patients with COPD who undergo esophagectomy. It is an open-label, randomized controlled trial conducted in a single center (EPITOPE study). A total of 32 enrolled patients are randomly assigned in a 1:1 ratio to either conventional management or inhalation of tiotropium in addition to the conventional management. Patients included in the intervention group receive tiotropium Respimat 5 μg (two inhalations of 2.5 μg) for at least 2 weeks before the esophagectomy. Following the esophagectomy, tiotropium is re-delivered, starting as early as possible and continuing until the postoperative evaluation (between 30 and 44 days after the operation). The primary outcome is the incidence of pneumonia within 30 days after esophagectomy. Secondary outcomes are the incidence of cardiovascular complications within 30 days after esophagectomy, the incidence of any postoperative complications within 30 days after esophagectomy, pulmonary function (preintervention, preoperative, and postoperative), walking distance in the incremental shuttle walking test (preintervention, preoperative, and postoperative), the incidence of adverse events, and mortality within 30 days after esophagectomy.
The EPITOPE study is the first pilot study on the effects of perioperative inhaled tiotropium on patients with COPD undergoing esophagectomy. After completing this study, we will plan a multicenter RCT with the appropriate outcomes in the future.
肺炎是食管癌手术后最常见的并发症之一，与手术死亡率增加有关。慢性阻塞性肺疾病（COPD）已知是肺部并发症和手术死亡率的一个危险因素。然而，在准备接受食管癌手术的 COPD 患者中，尚未发现针对术后肺炎的预防措施。在这项研究中，我们评估了围手术期吸入噻托溴铵（一种用于 COPD 管理的长效抗毒蕈碱支气管扩张剂）对接受食管癌手术的 COPD 患者的影响。
方法/设计：本研究调查了围手术期吸入噻托溴铵对接受食管癌手术的 COPD 患者的影响。这是一项在单中心进行的开放标签、随机对照试验（EPITOPE 研究）。总共纳入的 32 名患者按照 1:1 的比例随机分配至常规治疗组或常规治疗加吸入噻托溴铵组。干预组的患者在接受食管癌手术前至少 2 周接受噻托溴铵 Respimat 5μg（每次吸入 2.5μg，两次）治疗。食管癌手术后，尽早开始并持续到术后评估（手术后 30 至 44 天）期间，再次给予噻托溴铵。主要结局是食管癌手术后 30 天内肺炎的发生率。次要结局是食管癌手术后 30 天内心血管并发症的发生率、食管癌手术后 30 天内任何术后并发症的发生率、肺功能（干预前、术前和术后）、递增穿梭步行试验中的步行距离（干预前、术前和术后）、不良事件的发生率以及食管癌手术后 30 天内的死亡率。
EPITOPE 研究是第一项关于围手术期吸入噻托溴铵对接受食管癌手术的 COPD 患者影响的初步研究。完成这项研究后，我们将计划在未来进行一项具有适当结局的多中心 RCT。
