Wada Hideyuki, Ebihara Yuma, Takano Hironobu, Hayashi Mariko, Nitta Takeo, Shichinohe Toshiaki, Hirano Satoshi
Department of Gastroenterological Surgery II, Hokkaido University Faculty of Medicine Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan.
J Clin Med. 2025 Jan 23;14(3):717. doi: 10.3390/jcm14030717.
: Determining the optimal resection line for an organ that cannot be palpated is crucial, but challenging, in minimally invasive gastrointestinal (GI) surgery. Therefore, there is an urgent need to establish the most effective method for tumor localization. We hypothesize that our novel near-infrared (NIR) fluorescence detection system will enable the highly accurate detection of fluorescent clips marking GI cancer. : Twenty-five patients with gastric cancer, esophagogastric junctional cancer, or esophageal cancer will be enrolled. NIR fluorescent clips will be placed endoscopically around the tumor on the day before surgery. Patients in whom clip dislodgement is confirmed by preoperative abdominal radiography will be excluded. The clips will be placed before the transection of the organ, and those on the surgical specimen will be observed after transection using both the novel NIR fluorescence detection system and an existing NIR fluorescence imaging system. The detection rate and time, the fluorescence intensity, surgical margins, and adverse events will be evaluated. This study has been registered in the Japan Registry of Clinical Trials, with the code jRCTs012240043. () : As the novel fluorescence detection system allows for higher-sensitivity detection by analyzing the spectral characteristics of fluorescence and measuring the peak values, we anticipate that this new system will detect the fluorescent clips with high accuracy. : This study aims to establish a novel tumor-marking method using fluorescent clips and a new detection system that can be easily applied in various medical facilities.
在微创胃肠(GI)手术中,确定无法触及的器官的最佳切除线至关重要,但具有挑战性。因此,迫切需要建立最有效的肿瘤定位方法。我们假设我们的新型近红外(NIR)荧光检测系统将能够高精度地检测标记胃肠癌的荧光夹。
将招募25例胃癌、食管胃交界癌或食管癌患者。在手术前一天,通过内镜将NIR荧光夹放置在肿瘤周围。术前腹部X线检查确认夹子移位的患者将被排除。夹子将在器官横断前放置,横断后使用新型NIR荧光检测系统和现有的NIR荧光成像系统观察手术标本上的夹子。将评估检测率和时间、荧光强度、手术切缘和不良事件。本研究已在日本临床试验注册中心注册,注册号为jRCTs012240043。
由于新型荧光检测系统通过分析荧光的光谱特征和测量峰值实现更高灵敏度的检测,我们预计该新系统将高精度地检测荧光夹。
本研究旨在建立一种使用荧光夹的新型肿瘤标记方法以及一种可轻松应用于各种医疗机构的新检测系统。