Takahashi Naoto, Nimura Hiroshi, Fujita Tetsuji, Mitsumori Norio, Shiraishi Norio, Kitano Seigo, Satodate Hitoshi, Yanaga Katsuhiko
Department of Surgery, Kashiwa Hospital, The Jikei University School of Medicine, 163-1 Kashiwashita, Kashiwashi, Chiba, 277-0004, Japan.
Department of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Langenbecks Arch Surg. 2017 Feb;402(1):27-32. doi: 10.1007/s00423-016-1540-y. Epub 2016 Dec 20.
Prospective multicenter trials have shown the feasibility of sentinel node (SN) navigation surgery using a dual tracer of dye and radioisotope for early gastric cancer. However, comparable trials using the indocyanine green (ICG) and the infrared ray laparoscopic system (IRLS) have not been reported. On the basis of our cohort studies, we assumed that the ICG imaging with the IRLS is as effective as the dual tracer in detecting SNs. Therefore, we conducted a prospective multicenter trial to assess the effectiveness and generalizability of the infrared ICG technique in patients with early gastric cancer.
Patients with previously untreated cT1 gastric adenocarcinomas less than 4 cm in gross diameter were eligible for inclusion in this study. SN mapping was performed by using ICG combined with IRLS technique. Following biopsy of the identified SNs, D2 or modified D2 laparoscopic gastrectomy was performed according to the current Japanese Gastric Cancer Association guidelines.
Among the 47 patients who gave written informed consent, 44 were eligible from the surgical findings, for whom SN biopsy was performed. The detection rate of the lymphatic basin by the ICG with IRLS was 100% (44/44). The accuracy was also 100% (7/7) for detecting metastatic lymph node, which was verified on the permanent pathologic examination. Following the median follow-up of 114 months (range, 60 to 120 months), no recurrence (0/40) was observed. Although the number of patients was unequally distributed among the hospitals participating in the trial, the detection rates of SNs in low-volume hospitals were comparable to those in high-volume hospitals. Consequently, there was no learning curve in this trial.
The infrared ICG imaging accurately detected the lymphatic basin and SNs with occult metastasis in SN-navigated gastrectomy for gastric cancer. This method was feasible even for low-volume surgeons and hospitals.
前瞻性多中心试验已证明，使用染料和放射性同位素双示踪剂进行前哨淋巴结（SN）导航手术用于早期胃癌具有可行性。然而，尚未有使用吲哚菁绿（ICG）和红外线腹腔镜系统（IRLS）的类似试验报道。基于我们的队列研究，我们推测使用IRLS的ICG成像在检测SN方面与双示踪剂同样有效。因此，我们进行了一项前瞻性多中心试验，以评估红外线ICG技术在早期胃癌患者中的有效性和可推广性。
符合条件纳入本研究的患者为先前未经治疗、大体直径小于4 cm的cT1胃腺癌患者。使用ICG联合IRLS技术进行SN定位。在对确定的SN进行活检后，根据日本胃癌协会现行指南进行D2或改良D2腹腔镜胃切除术。
在47例签署书面知情同意书的患者中，根据手术结果有44例符合条件并进行了SN活检。使用IRLS的ICG对淋巴引流区的检测率为100%（44/44）。检测转移淋巴结的准确率也为100%（7/7），这在永久病理检查中得到证实。中位随访114个月（范围60至120个月）后，未观察到复发（0/40）。尽管参与试验的医院间患者数量分布不均，但低手术量医院的SN检测率与高手术量医院相当。因此，本试验不存在学习曲线。
在胃癌SN导航胃切除术中，红外线ICG成像能准确检测淋巴引流区及存在隐匿转移的SN。该方法即使对于低手术量的外科医生和医院也是可行的。
