Abstract 1392P
Background
Application of indocyanine green (ICG) fluorescence imaging is effective in guiding laparoscopic radical lymphadenectomy for gastric cancer. However, the optimal approach for ICG injection is controversial. We aimed to compare the efficacy and cost-effectiveness of ICG injection between the preoperative submucosal and intraoperative subserosal approaches for lymph node (LN) tracing during laparoscopic gastrectomy.
Methods
This phase III, open-label, randomized controlled trial was conducted at a tertiary teaching center in China. Patients aged 18–75 years who had cT1–cT4a, N0/+, M0 histologically proven gastric adenocarcinoma were randomly assigned (1:1) to receive either intraoperative subserosal injection or submucosal injection of ICG 1 day before surgery and underwent ICG fluorescence imaging-guided lymphadenectomy. The primary endpoint was the total number of retrieved LNs and was analyzed according to the modified intention-to-treat principle. The study is registered with ClinicalTrials.gov, number NCT04219332.
Results
Between December 31, 2019 and October 27, 2020, 266 patients were randomized to either the submucosal group (n=133) or the subserosal group (n=133). The full analysis set consisted of 130 participants in the submucosal group and 129 in the subserosal group. The mean (SD) total number of retrieved LNs was 49.8 (14.6) and 49.2 (14.0) in the submucosal and subserosal groups, respectively, with no significant difference (P=.71). The rate of LN noncompliance in the submucosal group was comparable to that in the subserosal group (32.3% vs. 33.3%, P=.86). The mean fluorescence cost in the submucosal group was higher than that in the subserosal group ($335.3 vs. $182.4; P<.001). The overall treatment satisfaction score was lower in the submucosal group than in the subserosal group (70.5 vs. 76.1%, P=.048).
Conclusions
ICG administered by subserosal injection was comparable to that administered by submucosal injection for LN tracing in gastric cancer. However, the former approach imposed a lower economic and mental burden on patients undergoing laparoscopic D2 lymphadenectomy.
Clinical trial identification
NCT04219332.
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.