Subserosal Indocyanine Green Plus Submucosal Carbon Nanoparticle Navigated Laparoscopic Gastrectomy (DANCE-01): a...

Indocyanine green (ICG) and carbon nanoparticle (CN) have been widely used for radical gastrectomy. However, synchronous application of ICG and CN in gastrectomy has not been tried yet. For the first time, we herein reported a novel strategy using dual tracers in laparoscopic radical gastrectomy.

This is a single-center, single-armed, prospective study. For each qualified patient, submucosal CN was injected the day before surgery, and subserosal ICG was injected immediately before surgery. Standard D2 laparoscopic gastrectomy and lymph node examination were subsequently performed. Demographics, lymph nodes (LNs) and postoperative outcome were collected for analysis. To analyze the safety and efficacy of this novel strategy, two contemporary historic control groups using single tracer were established.

A total of 60 patients underwent dual tracer laparoscopic gastrectomy and were divided into distal (n = 41) and total (n = 19) groups. An average of 53.3 and 62.2 LNs was harvested from two groups, respectively. The average operation duration was 213.3 and 250.0 min, and intra-operative blood loss was 100.2 ml and 94.7 ml. None received combined organ resection. Margin negativity and R0 resection were achieved in all patients. Three (7.3%) complications occurred in distal group. None required second operation or deceased. Postoperative hospitalization was 9.7 and 9.6 days, respectively. Compared to single tracer, more LNs (p < 0.01), shorter operation time (p < 0.01), less blood lost (p < 0.01) and accelerated postoperative recovery (p < 0.01) were observed in dual tracer group.

We propose a novel, feasible and safe tracing strategy for laparoscopic gastrectomy.

Chinese Clinical Trial Registry (ChiCTR2100051309).