Laparoscopic versus open pancreatoduodenectomy for periampullary tumors: A randomized clinical trial.

ABSTRACT

BACKGROUND: There is a lack of robust evidence on the efficacy of laparoscopic pancreatoduodenectomy compared to open surgery. This study was aimed to compare time to functional recovery (FR) between laparoscopic and open pancreatoduodenectomy. MATERIALS AND METHODS: This pragmatic, multicenter, randomized controlled phase 3 trial was conducted in seven tertiary centers. Patients with periampullary tumors were randomized using a block design in a 11 ratio and stratified by pancreatic fistula risk. Participants were randomized to undergo open or laparoscopic pancreatoduodenectomy by expert pancreatic surgeons. The primary outcome was the time to FR, defined as the number of days until FR was achieved in all five domains. The secondary endpoints included perioperative and short-term oncological outcomes. RESULTS: Between March 2019 and June 2022, 252 patients were randomly assigned to the laparoscopic (n=125) or open groups (n=127). Primary outcomes were reported in 235 patients. The mean time to FR was shorter in laparoscopic group compared to the open group (7.7 d vs. 9.0 d, P=0.03). Laparoscopic group exhibited a higher cumulative rate of FR compared to the open group (Hazard ratio,1.34; 95% confidence interval, 1.03-1.74; P=0.02). Severe complications, R0 resection, the number of retrieved lymph nodes and short-term survival rates were comparable between the two groups. CONCLUSION: Laparoscopic pancreatoduodenectomy demonstrated modest advantages in FR time over open surgery for selected patients with experienced surgeons.