Sato Masaaki, Kuwata Taiji, Yamanashi Keiji, Kitamura Atsushi, Misawa Kenji, Imashimizu Kota, Kobayashi Masashi, Ikeda Masaki, Koike Terumoto, Kosaka Shinji, Fukai Ryuta, Sekine Yasuo, Isowa Noritaka, Hirayama Shin, Sakai Hiroaki, Watanabe Fumiaki, Nagayama Kazuhiro, Aoyama Akihiro, Date Hiroshi, Nakajima Jun
Department of Thoracic Surgery, Kyoto University, Kyoto, Japan.
Department of Thoracic Surgery, The University of Tokyo, Tokyo, Japan.
Eur J Cardiothorac Surg. 2017 May 1;51(5):861-868. doi: 10.1093/ejcts/ezw395.
Virtual-assisted lung mapping (VAL-MAP) is a preoperative bronchoscopic multispot dye-marking technique using virtual images. The purpose of this study was to evaluate the safety, efficacy and reproducibility of VAL-MAP among multiple centres.
Selection criteria included patients with pulmonary lesions anticipated to be difficult to identify at thoracoscopy and/or those undergoing sub-lobar lung resections requiring careful determination of resection margins. Data were collected prospectively and, if needed, compared between the centre that originally developed VAL-MAP and 16 other centres.
Five hundred patients underwent VAL-MAP with 1781 markings (3.6 ± 1.2 marks/patient). Complications associated with VAL-MAP necessitating additional management occurred in four patients (0.8%) including pneumonia, fever and temporary exacerbation of pre-existing cerebral ischaemia. Minor complications included pneumothorax (3.6%), pneumomediastinum (1.2%) and alveolar haemorrhage (1.2%), with similar incidences between the original centre and other centres. Marks were identifiable during operation in approximately 90%, whereas the successful resection rate was approximately 99% in both groups, partly due to the mutually complementary marks. The contribution of VAL-MAP to surgical success was highly rated by surgeons resecting pure ground glass nodules ( P < 0.0001), tumours ≤ 5 mm ( P = 0.0016), and performing complex segmentectomy and wedge resection ( P = 0.0072).
VAL-MAP was found to be safe and reproducible among multiple centres with variable settings. Patients with pure ground glass nodules, small tumours and resections beyond conventional anatomical boundaries are considered the best candidates for VAL-MAP.
UMIN 000008031. University Hospital Medical Information Network Clinical Trial Registry ( http://www.umin.ac.jp/ctr/ ).
虚拟辅助肺绘图(VAL-MAP)是一种使用虚拟图像的术前支气管镜多点染料标记技术。本研究的目的是评估VAL-MAP在多个中心的安全性、有效性和可重复性。
选择标准包括预计在胸腔镜检查中难以识别肺部病变的患者和/或那些需要仔细确定切除边缘的亚肺叶肺切除术患者。前瞻性收集数据,如有需要,在最初开发VAL-MAP的中心和其他16个中心之间进行比较。
500例患者接受了VAL-MAP,共标记1781处(3.6±1.2处/患者)。需要额外处理的与VAL-MAP相关的并发症发生在4例患者(0.8%)中,包括肺炎、发热和原有脑缺血的暂时加重。轻微并发症包括气胸(3.6%)、纵隔气肿(1.2%)和肺泡出血(1.2%),在最初的中心和其他中心发生率相似。手术中约90%的标记可识别,而两组的成功切除率约为99%,部分原因是标记相互补充。切除纯磨玻璃结节(P<0.0001)、≤5mm肿瘤(P=0.0016)以及进行复杂肺段切除术和楔形切除术(P=0.0072)的外科医生对VAL-MAP对手术成功的贡献评价很高。
发现VAL-MAP在多个设置不同的中心是安全且可重复的。纯磨玻璃结节、小肿瘤以及超出传统解剖边界的切除术患者被认为是VAL-MAP的最佳候选者。
UMIN 000008031。大学医院医学信息网络临床试验注册中心(http://www.umin.ac.jp/ctr/)