Division of Gastric Surgery, Department of General Surgery, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Department of Anesthesiology, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Trials. 2023 Oct 2;24(1):624. doi: 10.1186/s13063-023-07676-4.
Lymph node (LN) metastasis is the most common metastasis route in gastric cancer. Extensive dissection of LNs can significantly improve the prognosis of patients with gastric cancer. Recently, multiple clinical studies have demonstrated that either indocyanine green (ICG) or carbon nanoparticles (CNs) can assist to promote the dissection of LNs during laparoscopic radical gastrectomy. Considering the pros and cons of the two tracers, this study proposed a novel method of dual tracer (ICG combined with CNs) for lymphatic tracing in laparoscopic gastric cancer surgery.
This trial is a prospective, randomized controlled trial (RCT) with an estimation of 516 participants that randomize into 4 groups (1:1:1:1), namely control group, ICG group, CNs group, and dual tracer group. The primary outcome is the number of dissected LNs. The secondary outcomes include positive rate, false positive rate, negative rate, false negative rate, number of metastatic LNs, relationship between LN metastasis and tracer stained, operation duration, blood loss, incision length, morbidity and mortality rate, 3-year DFS (disease free survival), PFS (progression-free survival), and OS (overall survival).
This study will investigate the efficacy and safety of a novel strategy using dual tracers for laparoscopic gastrectomy. The protocol has been approved by the Ethics Committee of Nanjing Drum Tower Hospital (2021-361-02). The trial findings will be published in peer-reviewed journals.
Chinese Clinical Trial Registry (ChiCTR2100051309). Registered 18 September 2021, https://www.chictr.org.cn/showproj.html?proj=133764 .
淋巴结（LN）转移是胃癌最常见的转移途径。广泛解剖 LN 可显著改善胃癌患者的预后。最近，多项临床研究表明，吲哚菁绿（ICG）或碳纳米粒子（CNs）均可辅助促进腹腔镜胃癌根治术中 LN 的解剖。考虑到两种示踪剂的优缺点，本研究提出了一种新的方法，即双重示踪剂（ICG 联合 CNs）用于腹腔镜胃癌手术中的淋巴示踪。
本试验为前瞻性、随机对照试验（RCT），预计纳入 516 例患者，随机分为 4 组（1:1:1:1），即对照组、ICG 组、CNs 组和双重示踪剂组。主要结局是解剖 LN 的数量。次要结局包括阳性率、假阳性率、阴性率、假阴性率、转移性 LN 的数量、LN 转移与示踪剂染色的关系、手术时间、出血量、切口长度、发病率和死亡率、3 年无病生存率（DFS）、无进展生存率（PFS）和总生存率（OS）。
本研究将探讨使用双重示踪剂行腹腔镜胃切除术的疗效和安全性。该方案已获得南京鼓楼医院伦理委员会批准（2021-361-02）。试验结果将发表在同行评议的期刊上。
中国临床试验注册中心（ChiCTR2100051309）。注册于 2021 年 9 月 18 日，https://www.chictr.org.cn/showproj.html?proj=133764。
