Dual tracer navigation for lymph node dissection in laparoscopic radical gastrectomy (DANCE trial): a protocol for a prospective, randomized clinical trial

Trials

Study Protocol

Yan Sun¹  Wenxian Guan²  Song Liu²  Shichao Ai²  Zhiyan Li²  Xiaofei Shen²  Peng Song²  Yanjun Lu²  Xiaofeng Lu²  Meng Wang²  Feng Sun²  Qiongyuan Hu² 

[1] Department of Anesthesiology, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China;Division of Gastric Surgery, Department of General Surgery, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China;

关键词: Lymph node;    Indocyanine green;    Carbon nanoparticles;    Gastric cancer;   

DOI  :  10.1186/s13063-023-07676-4

 received in 2023-07-22, accepted in 2023-09-26,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundLymph 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.MethodsThis 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).DiscussionThis 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.Trial registrationChinese Clinical Trial Registry (ChiCTR2100051309). Registered 18 September 2021, https://www.chictr.org.cn/showproj.html?proj=133764.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

Fig. 2