Enhanced recovery after surgery (ERAS) for endoscopic resection of upper gastrointestinal lesions ≤ 2 cm: a single-center, 1:2 randomized, controlled, non-inferiority trial

Objective: This study aimed to preliminarily evaluate the non-inferiority of ERAS-based perioperative management in endoscopic resection for upper gastrointestinal lesions. Methods: A total of 165 patients with upper gastrointestinal lesions ≤ 2 cm undergoing endoscopic resection (STER, ESD, ESE, or EFTR) were randomized 1:2 to the ERAS group (n = 55) or the conventional recovery after surgery (CRAS) group (n = 110). The primary outcome was postoperative complication rate, with a non-inferiority margin of 5%. Secondary outcomes included postoperative pain, recovery indicators, length of stay, and hospitalization costs. Results: The risk difference in postoperative complications between the ERAS group and the CRAS group was − 0.91% (90% CI [− 3.97% to 3.83%]), meeting the prespecified criterion for non-inferiority. The ERAS group also showed significantly lower VAS pain scores (0.0 [0.0–3.0] vs. 2.0 [0.0–3.3]; p = 0.020), shorter nasogastric tube duration (3.0 [2.0–3.0] vs. 4.0 [3.0–4.0] days; p < 0.001), and earlier time to first oral water (23.9 [18.5–32.5] vs. 64.7 [56.2–77.0] hours; p < 0.001), first oral feeding (33.2 [22.5–38.5] vs. 70.3 [59.2–79.8] hours; p < 0.001), and first ambulation (36.8 [27.0–45.5] vs. 76.1 [62.0–86.0] hours; p < 0.001). Postoperative length of stay, total length of stay, and hospitalization costs were also significantly reduced (all p < 0.001). Conclusion: In this single-center trial involving selected patients with upper gastrointestinal lesions ≤ 2 cm, ERAS met the prespecified criterion for non-inferiority to CRAS with respect to postoperative complications. ERAS was also associated with shorter hospital stays and lower hospitalization costs.