Study of Indocyanine Green Use to Improve Lymph Node Removal During Surgery for Resectable Gastric Cancer

What this Trial Is About

Researchers are evaluating the use of indocyanine green ICG to improve the removal of lymph nodes during surgery for gastric cancer. This study focuses on patients with resectable gastric adenocarcinoma at stages Ib, II, and III. The goal is to assess the safety and benefits of using ICG in lymph node dissection, which may help achieve more complete removal of affected lymph nodes and potentially improve patient outcomes. The study is a prospective, open-label trial conducted at a single center. All participants will receive total or subtotal gastrectomy with systematic lymphadenectomy classified as D1, D1, D2, or D2. Before surgery, ICG is injected by endoscopic submucosal injection at four points around the tumor between 12 and 24 hours prior to the operation. During surgery, fluorescent lymph nodes labeled by ICG will be identified, removed, and mapped. The injection procedure is performed under general anesthesia, with a total ICG dose of up to 20 mg. Participants will be monitored before and after surgery for side effects related to ICG and surgical complications. Postoperative complications will be classified using Clavien-Dindo criteria. The primary outcome is the average number of lymph nodes removed during surgery, measured 30 days after the operation. Secondary outcomes include the number of fluorescent and metastatic lymph nodes and the incidence of complications within 90 days. Patients will receive standard postoperative care, including gradual resumption of fluids and physical activity, with follow-up lasting three months after surgery.

Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer