碳纳米颗粒混悬液注射与吲哚菁绿示踪剂在胃癌根治术中指导淋巴结清扫的效果比较（FUTURE-01）：一项随机临床试验

Effect of carbon nanoparticle suspension injection versus indocyanine green tracer in guiding lymph node dissection during radical gastrectomy (FUTURE-01): a randomized clinical trial.

作者信息

Tian Yuan, Pang Yue, Yang Peigang, Guo Shuo, Ma Wenqian, Guo Honghai, Liu Yang, Zhang Ze, Ding Pingan, Zheng Tao, Li Yong, Fan Liqiao, Zhang Zhidong, Wang Dong, Zhao Xuefeng, Tan Bibo, Liu Yu, Zhao Qun

机构信息

Third Surgery Department, The Fourth Hospital of Hebei Medical University.

Hebei Key Laboratory of Precision Diagnosis and Comprehensive Treatment of Gastric Cancer.

出版信息

Int J Surg. 2025 Jan 1;111(1):609-616. doi: 10.1097/JS9.0000000000001873.

DOI:10.1097/JS9.0000000000001873

PMID:38954670

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11745718/

Abstract

BACKGROUND

Carbon nanoparticle suspension injection (CNSI) and indocyanine green (ICG) have both been applied intraoperatively to facilitate lymphatic mapping and postoperatively to sort lymph nodes (LNs) in gastric cancer patients. However, no study has compared the two tracers in gastric cancer patients.

MATERIALS AND METHODS

This prospective randomized controlled trial was conducted from January 2022 to March 2023. Patients with potentially resectable gastric cancer (cT1-4a N0/+ M0) were randomized to the CNSI or ICG group.

RESULTS

This study enrolled 96 patients. Ninety patients were in the modified intention-to-treat population, including 46 patients [32 males and 14 females; mean (SD) age, 57.4 (9.4) years] in the CNSI group and 44 patients [31 males and 13 females; mean (SD) age, 60.8 (8.8) years] in the ICG group. The mean (SD) number of retrieved LNs was 69.8 (21.9) and 53.6 (17.2) in the CNSI and ICG groups, respectively ( P <0.001). The mean (SD) number of retrieved micro-LNs was 19.9 (13.3) and 11.6 (9.9) in the CNSI and ICG groups, respectively ( P =0.001). The mean (SD) number of metastatic LNs was 8.1 (11.9) and 5.2 (9.2) in the CNSI and ICG groups, respectively ( P =0.19).

CONCLUSIONS

Compared with ICG, CNSI can increase the number of LNs detected, especially micro-LNs. Both tracers have high diagnostic value for detecting metastatic LNs. CNSI-guided lymphography may be a superior method for improving the accuracy of LN dissection.

摘要

背景

碳纳米颗粒混悬液注射（CNSI）和吲哚菁绿（ICG）均已在术中应用以促进淋巴绘图，并在术后用于对胃癌患者的淋巴结（LN）进行分类。然而，尚无研究在胃癌患者中比较这两种示踪剂。

材料与方法

这项前瞻性随机对照试验于2022年1月至2023年3月进行。将具有潜在可切除胃癌（cT1 - 4a N0/+ M0）的患者随机分为CNSI组或ICG组。

结果

本研究共纳入96例患者。90例患者纳入改良意向性分析人群，其中CNSI组46例患者[32例男性和14例女性；平均（标准差）年龄，57.4（9.4）岁]，ICG组44例患者[31例男性和13例女性；平均（标准差）年龄，60.8（8.8）岁]。CNSI组和ICG组回收的LN平均（标准差）数量分别为69.8（21.9）和53.6（17.2）（P<0.001）。CNSI组和ICG组回收的微LN平均（标准差）数量分别为19.9（13.3）和（11.6）9.9（P = 0.001）。CNSI组和ICG组转移LN的平均（标准差）数量分别为8.1（11.9）和5.2（9.2）（P = 0.19）。