Three-year Survival Outcomes of Patients With Enhanced Recovery After Surgery Versus Conventional Care in Laparoscopic Distal Gastrectomy: The GISSG1901 Randomized Clinical Trial.

[OBJECTIVE] The efficacy of enhanced recovery after surgery (ERAS) to improve the prognosis of patients who undergo laparoscopic distal gastrectomy (LDG) for gastric cancer is uncertain. This randomized study compared oncological outcomes in LDG after ERAS or conventional care.

[BACKGROUND] At present, randomized controlled trials have confirmed that ERAS can improve the short-term clinical outcomes of patients undergoing LDG, but whether it improves survival has not been reported yet.

[METHODS] A multicenter, randomized, controlled trial was performed to compare oncological outcomes of ERAS versus conventional care in LDG. Between April 4, 2019 and March 18, 2020, 527 patients with locally advanced lower gastric adenocarcinoma were recruited from 13 centers in China. The primary endpoints were 3-year overall survival (OS) and disease-free survival (DFS). The secondary endpoints were complications, mortality, recovery, time of receiving adjuvant chemotherapy, and medical expenses.

[RESULTS] The full analysis set included 186 cases in the ERAS group and 184 in the conventional group, well balanced with respect to patient demographics and baseline characteristics (published before). Postoperative hospital stay and the interval before adjuvant chemotherapy were obviously shorter in the ERAS group compared with the conventional group as reported previously and with lower medical expenses. Compared with the conventional group, the ERAS group had fewer overall complications (21.0% vs 30.4%, respectively; P = 0.037). The median (interquartile range) follow-up for all cases was 42.17 (range: 3.12-48.50) months. The 3-year OS and DFS in the ERAS group and conventional group were 86.56% and 80.11% (log-rank P = 0.025), 79.57% and 69.57% (log-rank P = 0.027), respectively. In a subgroup analysis of stage I and II disease patients, 3-year OS and DFS were similar between the groups ( P = 0.901; P = 0.859 for stage I and P = 0.421; P = 0.459 for stage II). However, in the stage III disease, the ERAS group exhibited longer 3-year OS and DFS than the conventional group (79.41% vs 64.47% for OS, log-rank P = 0.046; 70.59% vs 53.95% for DFS, log-rank P = 0.046).

[CONCLUSIONS] Patients undergoing ERAS LDG had fewer overall complications, shorter hospital stays, decreased medical expenses, and improved 3-year OS and DFS rates, particularly in cases with stage III gastric cancer.