Use of sentinel node mapping with dual tracer versus D2 lymphadenectomy in patients with early gastric cancer: a multicenter randomized clinical trial

Abstract

Background: The most accepted surgical approach for gastric cancer is total or partial gastrectomy plus D2 lymphadenectomy. This implies that patients with early gastric cancer (EGC) undergo extensive lymphadenectomy, which is in most cases unnecessary, resulting in significant morbidity. To reduce these complications, the use of the sentinel lymph node technique has been proposed in these patients. Studies have shown that the best results are obtained with dual tracer techniques, with promising results. However, there is a lack of information from clinical trials comparing both techniques. Objective: Study whether the use of sentinel node mapping using dual tracer (patent blue V and 99mTc-Antimony Sulfur Colloid) in patients with EGC achieves similar survival rate with less morbidity as compared to the conventional approach of D2 lymphadenectomy. Other variables like length of stay and quality of life will be also compared between both techniques. Design: Multicenter, randomized, clinical trial conducted in Hospital Universitari Doctor Josep Trueta and six hospitals of Barcelona between 2017 and 2026. Participants: Using a non-probabilistic consecutive sampling, 190 patients older than 18 years old presenting an early gastric cancer with tumor size ≤3 cm will be recruited. Intervention: Patients will be randomized in a 1:1 ratio to sentinel node mapping (n=95) or D2 lymphadenectomy (n=95). Main outcomes: Assess if the sentinel node technique achieves a disease-free survival and an overall survival rate comparable to D2 lymphadenectomy after five years of follow-up. Moreover, we will compare the complications rates between both techniques during the first month after the intervention. Statistical analysis: To compare the intervention performed and morbidity, we will use a Chi-square test. To study the overall and the disease-free survival rate, we will use the Kaplan-Meier estimator. For the multivariate analysis, we will use a multiple logistic regression model for the morbidity and Cox models for the overall and disease-free survival rate