Comparison of a submucosal and subserosal approach in ICG-guided laparoscopic lymphadenectomy in gastric cancer patients: long-term outcomes of a phase 3 randomized clinical trial.

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Tác giả: Jun-Yun Chen, Qi-Yue Chen, Chang-Ming Huang, Ze-Ning Huang, Ping Li, Zhi-Yu Liu, Zhi-Xin Shang-Guan, Hua-Gen Wang, Dong Wu, Jin-Xun Wu, Jian-Wei Xie, Chao-Hui Zheng, Qing Zhong

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: United States : International journal of surgery (London, England) , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 701693

BACKGROUND: Previous studies have demonstrated similar short-term efficacy between subserosal (SSA) and submucosal (SMA) approaches for ICG injection in gastric cancer (GC). This study aims to compare the long-term oncological outcomes of these two injection methods for lymph node (LN) tracing in ICG-guided laparoscopic gastrectomy. MATERIALS AND METHODS: This study was a phase 3, open-label, randomized clinical trial (FUGES-019). A total of 266 patients with resectable gastric adenocarcinoma (cT1-4a, N0/ +, M0) were enrolled. We report predefined long-term secondary outcomes, including three-year actual overall survival (OS), three-year actual disease-free survival (DFS), and recurrence patterns. RESULTS: Of the 266 participants, 259 patients were included in the per-protocol analysis: 129 in the SSA group and 130 in the SMA group. The actual OS in the SSA group (87.6%) was comparable to that in the SMA group (90.8%, P = 0.41), as were the 3-year actual DFS rates (SSA: 82.9% vs. SMA: 88.5%, log-rank P = 0.19). Per-protocol analysis confirmed the equivalence of the SSA compared with the SMA. The most common type of recurrence was multiple site metastasis (11 of 259[4.24%]), with no differences in recurrence types across cancer stages. Further stratified analysis based on pT, pN staging, tumor size, and BMI showed no significant differences between the two groups. CONCLUSION: The 3-year outcomes of the FUGES-019 trial confirm the equivalence of SSA and SMA in ICG-guided laparoscopic lymphadenectomy for GC, supporting the previous short-term findings. The subserosal approach can be recommended for ICG administration based on clinical considerations.
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