腹腔镜胃癌手术中 ICG(吲哚菁绿)荧光法和 OSNA(一步法核酸扩增)检测用于单示踪剂前哨淋巴结检测的前瞻性可行性研究。
Prospective feasibility study for single-tracer sentinel node mapping by ICG (indocyanine green) fluorescence and OSNA (one-step nucleic acid amplification) assay in laparoscopic gastric cancer surgery.
机构信息
Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
出版信息
Gastric Cancer. 2019 Jul;22(4):873-880. doi: 10.1007/s10120-018-00919-3. Epub 2019 Jan 3.
BACKGROUND
The double-tracer method has been established for sentinel node (SN) mapping in gastric cancer surgery. However, there remain several unresolved issues that prevent its widespread use in clinical practice. In this study, we aimed to demonstrate the feasibility of single-tracer SN mapping in laparoscopic surgery for gastric cancer, using indocyanine green (ICG) fluorescence imaging with a one-step nucleic acid amplification (OSNA) assay intraoperatively.
METHODS
Patients with clinical T1N0M0 gastric adenocarcinoma preoperatively were considered for inclusion if they had a single primary lesion 4 cm or less in maximal diameter. Immunohistochemical staining with the anti-cytokeratin 19 antibody was performed on preoperative biopsy specimens, and patients with faint positive reactions were excluded. Intraoperatively, single-tracer SN biopsy with ICG fluorescence imaging was performed, followed by laparoscopic gastrectomy with modified D1+ or D2 lymph node dissection.
RESULTS
Twenty eligible patients underwent SN biopsy and laparoscopic gastrectomy. SNs were identified in 17 cases (85%), with a median number of three SNs per patient. The median times for SN mapping and OSNA assay were 19 and 35 min, respectively. OSNA assay detected one metastatic lymph node, but all other nodes were negative. No adverse effects were observed in relation to SN mapping.
CONCLUSIONS
Single-tracer SN mapping by ICG fluorescence imaging with intraoperative diagnosis by OSNA assay is feasible and safe. SNs can be identified in most patients, without producing false-negative results. Further clinical trial to demonstrate the sensitivity is ongoing.
背景
双示踪剂法已被确立用于胃癌手术中的前哨淋巴结(SN)定位。然而,仍存在一些未解决的问题,阻碍了其在临床实践中的广泛应用。在这项研究中,我们旨在通过术中吲哚菁绿(ICG)荧光成像联合一步式核酸扩增(OSNA)检测,证明单示踪剂 SN 定位在腹腔镜胃癌手术中的可行性。
方法
术前临床 T1N0M0 胃腺癌患者,如果最大直径为 4cm 或以下的单个原发性病变,可考虑纳入研究。对术前活检标本进行抗细胞角蛋白 19 抗体免疫组织化学染色,如果有微弱阳性反应则排除患者。术中,行 ICG 荧光成像引导的单示踪剂 SN 活检,然后行腹腔镜胃切除术并改良 D1+或 D2 淋巴结清扫。
结果
20 例符合条件的患者接受了 SN 活检和腹腔镜胃切除术。17 例(85%)患者识别出 SN,每位患者的中位 SN 数量为 3 个。SN 定位和 OSNA 检测的中位时间分别为 19 和 35min。OSNA 检测到一个转移性淋巴结,但所有其他淋巴结均为阴性。SN 定位未观察到不良反应。
结论
ICG 荧光成像引导的单示踪剂 SN 定位,术中结合 OSNA 检测进行诊断,是可行且安全的。大多数患者都可以识别 SN,不会产生假阴性结果。正在进行进一步的临床试验以证明其敏感性。