Activity and Physiological Stress Within 90 Days After Minimally Invasive and Open Pancreatoduodenectomy: A Predefined Analysis of the DIPLOMA-2 Randomized Clinical Trial

Importance: Minimally invasive pancreatoduodenectomy (MIPD) aims to improve postoperative recovery compared with open pancreatoduodenectomy (OPD). However, it is unclear whether the benefits of MIPD extend beyond the initial hospital stay. Objective: To assess postoperative recovery after hospital discharge - using activity tracking - in patients with upfront resectable neoplasm in the pancreatic head or periampullary region, comparing MIPD with OPD. Design, Setting, and Participants: The patient-blinded DIPLOMA-2 randomized clinical trial was conducted between 2022 and 2023. This was an international, multicenter trial in 14 high-volume centers in 6 European countries. Included in the analysis were patients with suspected or proven upfront resectable neoplasm (ie, without vascular contact) in the pancreatic head or periampullary region. Study data were analyzed from January 2024 to January 2025. Interventions: Patients were randomly assigned to undergo MIPD or OPD (2:1 ratio). Patients wore an activity tracker (Fitbit Inspire 2 [Google]) from 2 weeks before surgery until 90 days thereafter. The tracker monitored step count, active minutes, and heart rate variability (HRV), wherein high HRV reflects parasympathetic activity and thus physiological relaxation and recovery. Main Outcomes and Measures: Postoperative physical activity in the first 90 postoperative days. Results: A total of 288 patients (mean [SD] age, 68.3 [9.9] years; 168 male [58.3%]) were included in this analysis. Activity tracker data were available from 236 of 288 patients (82%; 155 in the MIPD and 81 in the OPD groups). On postoperative day 30, patients in the MIPD group averaged 659 more steps daily (95% CI, 79-1240 steps; P =.03), had 22 more active minutes daily (95% CI, 3-40 minutes; P =.03), and had a 9-millisecond higher HRV (95% CI, 2-15 milliseconds; P =.006), compared with the OPD group. On postoperative day 90, step count and active minutes were comparable between groups, but HRV remained higher in the MIPD group. Patients after MIPD had a significantly higher step count between postoperative day 16 and 39 and more active minutes between day 14 and 37. Conclusions and Relevance: In this randomized clinical trial, activity tracking up to 90 days revealed increased physical activity up to 5 weeks after MIPD and less physiological stress up to 3 months, as compared with OPD. Future studies should confirm whether these relatively modest benefits persist in other settings, such as lower-volume centers.