The therapeutic effect of novel endoscopic submucosal dissection with lymph node dissection surgery on T1 ESCC: A single center, prospective, and nested case-control study

BACKGROUND: Endoscopic submucosal dissection is effective for treating T1 early esophageal squamous cell carcinoma. However, there is a risk of lymph node metastasis . Standard radical surgery may be overtreatment for T1 ESCC. This trial was designed to clarify the efficacy of novel dual-scopy combined surgery in the treatment of T1 ESCC. METHODS: Between December 2021 and May 2025, 21 patients underwent dual-scopy combined surgery, 197 underwent ESD, and 213 underwent radical surgery for early (T1 stage) ESCC. This study included 63 patients who underwent ESD, dual-scopy combined surgery, and standard radical surgery (1:1:1) in the efficacy analysis. The patients' overall survival, recurrence-free survival, disease-specific survival, complications, and clinical outcomes were evaluated. RESULTS: There was no significant difference among the three groups in OS, RFS, and DSS. Complication rates were similar between the ESD and dual-scopy groups, both lower than in the radical surgery group. Compared to the radical surgery group, the ESD and dual-scopy groups demonstrated significantly shorter hospital stays and lower costs. Postoperative quality of life and nutritional levels were better in both the ESD and dual-scopy groups compared to radical surgery. CONCLUSIONS: For T1-stage ESCC patients without clear metastasis, the novel dual-scopy combined surgery may achieve lesion resection and lymph node dissection without affecting patient survival. Moreover, it may reduce postoperative complications, hospitalization time, and costs, and potentially improve quality of life and nutritional status compared to standard radical surgery. TRIAL REGISTRATION: This study was registered as a clinical trial with the China Clinical Trial Registration Center (ChiCTR2100053603).