Clinical study on harvesting lymph nodes with carbon nanoparticles for advanced gastric cancer: A prospective randomized trail.

Abstract

159 Background: There were no ideal materials nor quantizing regime for surgeons’ training on harvesting lymph nodes in advanced gastric cancer(AGC). A prospective randomized trial on Carbon Nanoparticles (CNP),a kind of lymphatic tracers, was designed to find a solution. Methods: Patients with previously untreated resectable AGC were eligible for inclusion in this study. All patients were randomly allocated to two subgroups. In experimental group, total of 1.0 mL CNP was injected into the subserosa of stomach around the tumor before gastrectomy with D2 dissection performed. On the contrary, the same procedure was performed directly without any coloring materials in control arm. Following surgery,the investigator harvested lymph nodes (LNs), counted colored LNs and measured the diameters with pathologist. Results: 30 patients were enrolled in the study. We observed no serious adverse effects related to CNP injection. The rate of stained LNs was 46.6%. The mean number of harvested LNs was larger in experimental than control group (38.33 vs. 28.27, p=0.041). Smaller diameter was recorded in experimental arm (3.32vs4.30mm,p=0.023), which might clarify the reason why the number of LNs was larger with CNP. In addition, we set up a model for predicting total number of LNs based on the data of CNP-staining LNs and metastatic LNs(MLNs), which might help the surgeons review their work of removing LNs so as to improve their surgical skills. Conclusions: CNP was a kind of safe materials and surgeons could harvest more LNs with it in AGC, which might benefit from the harvest of more smaller ones. Further study was needed to prove the model’s practicability. Clinical trial information: NCT02123407.