Randomized Trial Comparing Endoscopic Submucosal Dissection and Surgery for Early Undifferentiated Gastric Cancer

What this Trial Is About

Researchers are evaluating the clinical and cost-effectiveness of endoscopic submucosal dissection ESD compared to surgery in patients with early gastric cancer EGC of the undifferentiated type that meets expanded indications. This multi-center, randomized controlled trial aims to provide high-level evidence due to limitations in previous retrospective studies. ESD is a less invasive treatment preserving the stomach, potentially improving quality of life and reducing medical costs compared to surgery, which remains the standard treatment. Participants are randomly assigned to one of two groups the endoscopic submucosal dissection group, where an endoscopist performs the procedure using specialized devices, or the surgery group, where a surgeon performs gastrectomy with lymph node dissection. The study focuses on tumors confined to the mucosa without ulcers, 2 cm or smaller, with no lymph node or distant metastasis detected. This trial includes adults aged 19 to 75 and follows them over several years to assess outcomes. During the study, participants undergo evaluations including imaging and endoscopic assessments. Researchers monitor disease-free survival over three years as the primary outcome, along with secondary outcomes such as overall survival, curative resection rates, quality of life changes, treatment complications, and cost-effectiveness. Follow-up and assessments continue for up to five years after enrollment to gather comprehensive data on treatment impact and safety.

Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type