Efficacy and safety of subserosal versus submucosal carbon nanoparticle-guided laparoscopic radical gastrectomy (DANCE-04): A randomized clinical trial.

Abstract

To compare the efficacy in lymph node dissection, perioperative safety, and cost of subserosal and submucosal administration of carbon nanoparticles in laparoscopic radical gastrectomy for gastric cancer. This was a randomized clinical trial. Patients with potentially resectable gastric cancer (cT1-4a, cNany, cM0) were randomized into subserosal or submucosal groups. Laparoscopic D2 lymphadenectomy was performed for each patient. Between September 2023 and August 2024, 49 patients were enrolled in the subserosal group and 50 patients were enrolled in the submucosal group. The number of retrieved lymph nodes in the subserosal group was significantly greater than that in the submucosal group (36.6 ± 1.4 vs 32.2 ± 1.4, P = .02). The number of retrieved metastatic lymph nodes in the subserosal group was also significantly greater than that in the submucosal group (3.1 ± 0.6 vs 1.5 ± 0.5, P = .04). The duration of surgery in the subserosal group was shorter than that in the submucosal group (150.9 ± 3.0 minutes vs 194.7 ± 6.2 minutes, P < .001). The tracing-related cost in the subserosal group was lower than that in the submucosal group (1,824.8 ± 110.9 vs 2,395.5 ± 112.5 [in Chinese currency], P < .001), whereas the tracing-excluded cost was similar between groups. Diagnostic values, including sensitivity, specificity, positive predictive value, and negative predictive value for metastatic stations or lymph nodes, of the subserosal approach were superior to those of the submucosal approach. Subserosal is superior to submucosal administration of carbon nanoparticles in lymph node dissection with comparable perioperative safety and decreased tracing-related cost in laparoscopic radical gastrectomy for gastric cancer. ISRCTN11247387 (https://doi.org/10.1186/ISRCTN11247387).