77P - Long-term outcomes of indocyanine green fluorescence imaging-guided laparoscopic lymphadenectomy for gastric cancer: The FUGES-012 randomized clinical trial

Background

Radical lymph nodes (LNs) dissection is the cornerstone of gastric cancer (GC) surgical treatment. Indocyanine green (ICG) fluorescence imaging-guided lymphadenectomy has been proven to be effective in increasing the number of LNs retrieved in laparoscopic gastrectomy (LG) for GC. However, the long-term oncological efficacy of ICG fluorescence imaging in LG remains uncertain. This randomized clinical trial was conducted to evaluate the long-term oncological efficacy of ICG imaging-guided laparoscopic lymphadenectomy for GC.

Methods

The study was an open-label, randomized clinical trial conducted at a tertiary referral teaching hospital in China. A total of 266 eligible patients with potentially resectable GC (cT1-4a, N0/+, M0) without bulky nodes or distant metastases were enrolled from November 2018 to July 2019. Patients were randomly (1:1 ratio) assigned to the ICG group or the non-ICG group.

Results

Among 266 patients, 258 (97.0%; mean age, 58.9 years; 85 [32.9%] women) completed the study. The mean (SD) total number of LNs retrieved in the ICG group was 50.5 (15.9), which was significantly more than that of the non-ICG group (42.0 [10.3], P < 0.001). The 3-year disease-free survival (DFS) of the ICG group and the non-ICG group were 81.4% and 68.2%, respectively, with an absolute risk difference of 13.2% (Log-rank P = 0.012). The 3-year overall survival (OS) in the ICG group was 86.0%, which was significantly higher than that in the non-ICG group (73.6%; Log-rank P = 0.015). Cox multivariate analysis showed ICG was the independent protective factor for both OS and DFS (OS: HR=0.49, 95%CI: 0.27-0.91; P = 0.023; DFS: HR=0.51, 95%CI: 0.30-0.87; P = 0.014).There were differences in overall recurrence patterns between the ICG and non-ICG groups within 3 years after surgery (17.9% vs. 31.0%, P = 0.014).

Conclusions

For patients with resectable GC, ICG fluorescence imaging-guided laparoscopic lymphadenectomy showed better long-term oncological efficacy than conventional LN dissection, especially in patients undergoing total gastrectomy. These findings provided encouraging evidence for the ongoing, randomized, phase 3, CLASS-11 study (NCT03875235).

Clinical trial identification

NCT03875235.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.