The safety and effectiveness of carbon nanoparticles suspension in tracking lymph node metastases of colorectal cancer: a prospective randomized controlled trial

Objective: This study was to evaluate the safety and effectiveness of carbon nanoparticles suspension in tracking lymph node metastases of colorectal cancer. Methods: Eligible patients diagnosed with stages I-III colorectal cancer in Fudan University Shanghai Cancer Center between 1 May 2017 and 31 May 2018 fulfilling the inclusion criteria were included in this prospective randomized controlled study. All the patients were randomly allocated to two groups: the nanocarbon group and the control group. Patients' clinicopathological characteristics were compared between the nanocarbon group and the control group. For continuous variables, data were presented as mean (SD) and differences between the two groups were compared by the Mann-Whitney U test; for categorical variables, data was presented as frequency (%) and the Pearson's chi-squared test was used to compare the differences between two groups. Results: All the patients' characteristics between two groups did not achieve statistical significance (P > 0.05). Patients in nanocarbon group were more likely to be associated with more lymph nodes retrieved totally compared with control group (19.84 6.428 vs. 17.41 +/- 7.229, P < 0.001). The number of lymph nodes retrieved in nanocarbon group were more likely to be >= 12 than that in the control group (P = 0.005). Conclusions: Our study confirmed the safety of using carbon nanoparticles suspension as a tracer in colorectal cancer. More importantly, nanocarbon could significantly increase the detected number of lymph nodes in colorectal cancer, which can help improve the accuracy of lymph node staging and even improve patients' survival.