RecruitingNot ApplicableNCT06788548

Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer

Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study

Sponsor

Beijing Friendship Hospital

Enrollment

312 participants

Start Date

Feb 3, 2024

Study Type

INTERVENTIONAL

Conditions

Early Gastric Cancer

Summary

The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new surgical technique for early stomach cancer that uses fluorescent dye and a tiny camera to find and remove the specific lymph nodes (small glands in the body that cancer may spread to) most likely to contain cancer cells. The goal is to identify whether the cancer has spread without removing all nearby lymph nodes unnecessarily. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with early-stage stomach cancer (cT1N0M0 — cancer that has not spread beyond the stomach lining or nearby lymph nodes) - OR you previously had an endoscopic procedure for stomach cancer that was not curative and now need surgery - You are fit enough for surgery and have normal organ function - You have not had prior stomach surgery, chemotherapy, or radiation therapy **You may NOT be eligible if...** - You have had previous stomach or gastrointestinal surgery - You have had prior chemotherapy or radiation - Your organ function (liver, kidney, heart, bone marrow) is not adequate - You are not able to understand or follow the study instructions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery

Patients without prior ESD received ESD with laparoscopic sentinel basin dissection (LSBD) for ESD resectable lesions, otherwise patients received laparoscopic-endoscopic cooperative regional gastrectomy (LRG) with LSBD. For patients with prior non-curative ESD, LSBD alone was performed if margins were negative, otherwise LRG with LSBD was conducted. LECS-SNNS adopted a left-sided surgical approach. During laparoscopic sentinel node basin dissection (LSBD), indocyanine green (ICG) (2 mL, 2.5 mg/mL) was endoscopically injected into the submucosal layer at four quadrants around the marking points (0.5 mL per quadrant). Sentinel lymph node basins (SLBs) were defined as the area within a 2 cm margin of the detected fluorescence stained nodes, which were marked with laparoscopic clips. Fifteen minutes after ICG injection, the SLBs were examined first under white light and then using fluorescence imaging. Staining status was determined by consensus among surgeons and endoscopists.

PROCEDURELaparoscopic D2 radical gastrectomy

Preparation: The patient is positioned supine with general anesthesia. An orogastric tube and Foley catheter are inserted. Antibiotics are administered, and sequential stockings are applied. Port Placement: Pneumoperitoneum is created via a Veress needle at the umbilicus. Working ports are placed in the upper quadrants, with a fifth port for liver retraction. Abdominal Exploration: The abdomen is inspected for metastases, and peritoneal cytology is performed. Dissection and Lymph Node Removal: The lesser omentum is divided near the liver, reaching the cardia and diaphragm. The gastrocolic ligament is divided along the transverse colon. Lymph node dissection begins along the splenic artery, then proceeds to the left gastric artery and celiac nodes. The left gastric vessels are controlled with endoclips.After lymph node dissection, distal subtotal gastrectomy is performed. Digestive tract reconstruction is typically done through a mini-laparotomy.