Comparison of short-term outcomes and oncological outcomes between totally laparoscopic distal gastrectomy and pylorus-preserving gastrectomy for early gastric cancer in the middle stomach: a non-inferiority randomised controlled trial

Background: The surgical treatment of early gastric cancer (EGC) has shifted toward minimally invasive, precise, and function-preserving strategies, such as totally laparoscopic distal gastrectomy (TLDG) and totally laparoscopic pylorus-preserving gastrectomy (TLPPG). However, systematic evidence directly comparing their efficacies is lacking. Methods: A total of 95 patients with EGC were randomly assigned to the TLDG (63) and the TLPPG (32) groups between 2020 and 2024. The primary outcome was 20-month recurrence-free survival (RFS). Secondary outcomes included surgical parameters, postoperative recovery, complications (Clavien-Dindo classification), quality of life (QOL), and overall survival. To address baseline imbalances, propensity score matching (PSM) was performed as a sensitivity analysis. Results: TLPPG showed significantly shorter operative times (225.6 vs. 272.4 minutes, P = 0.002) and hospital stays (9.2 vs. 10.5 days, P = 0.016) but a higher incidence of delayed gastric emptying (12.5% vs. 1.6%, P = 0.024). Multivariate analysis identified diabetes (revised odds ratio = 8.23, P < 0.05) as a risk factor for delayed gastric emptying. TLPPG patients exhibited better postoperative nutritional status, with significantly higher body mass index, hemoglobin, and albumin levels at 6 and 12 months (P < 0.05). PGSAS-37 scores indicated superior QOL in the TLPPG group, particularly in weight change and meal intake (P < 0.05). The lymph node yield was higher in the TLDG group (27.9 ± 5.1 vs. 24.9 ± 4.7, P = 0.008), but oncological outcomes were comparable, with 20-month overall survival (OS) rates of 95.24% (TLDG) and 100% (TLPPG, P = 0.210) and no significant difference in RFS (P = 0.497). PSM confirmed these findings in a balanced cohort (n = 64), with RFS P = 0.556. Conclusion: TLDG and TLPPG are safe and oncologically equivalent for EGC. TLPPG benefits postoperative nutrition and QOL by preserving pyloric function, despite a higher risk of delayed gastric emptying. Patient selection should consider tumor location, stage, and patient-specific needs, with TLPPG suitable for carefully selected early-stage cases to enhance functional outcomes. Long-term follow-up (ongoing at 3 years) is warranted to validate sustained benefits.