Safety and efficacy of indocyanine green-guided laparoscopic lymphadenectomy for locally advanced gastric cancer: The CLASS-11 clinical trials.

We report the short-term results of indocyanine green (ICG)-guided laparoscopic lymphadenectomy for gastric cancer (GC). The primary outcome is 3-year disease-free survival. In this analysis, we present short-term secondary outcomes focused on the number of lymph nodes (LNs) retrieved and the diagnostic value of fluorescent status for metastatic LNs, excluding long-term outcomes. A total of 1,006 patients are included in the per-protocol analysis. The mean number of LNs retrieved in the ICG group is significantly higher than that in the non-ICG group. The negative predictive value is 93.9% for nonfluorescent stations, and the sensitivity of ICG for detecting all metastatic LN stations is 91.6%. ICG technology is safe and feasible for laparoscopic lymphadenectomy in GC and can noticeably increase the number of LNs retrieved. Further follow-up is necessary to warrant whether ICG can improve long-term survival of GC. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS)-11 trial has been registered at ClinicalTrials.gov as NCT04593615.