Early Detection and Minimally Invasive Management of Complications Reduces Mortality after Pancreatic Resection: The Nationwide PORSCH Trial

Purpose: To evaluate if the nationwide implementation of a multilevel algorithm for early detection and minimally invasive management of complications decreases major complications and death after pancreatic resection. Method: We conducted a nationwide stepped-wedge cluster randomized trial including all patients undergoing pancreatic resection over a 22-month period in The Netherlands. The algorithm included daily evaluation of clinical and biochemical inflammatory parameters. The advice to perform abdominal computed tomography (CT) scan was given when predefined cut-off points were exceeded. If CT showed suspicion of (inadequately drained) pancreatic fistula, minimally invasive percutaneous drainage was advised. Analysis was performed using mixed-effects logistic regression adjusting for confounders. The primary outcome was a composite of bleeding requiring invasive intervention, organ failure and death within 90 days after resection. Results: 1748 patients were included. The primary endpoint occurred in 124 of 885 patients assigned to usual care (14.0%) and in 73 of 863 patients (8.5%) assigned to the algorithm (adjusted Odds Ratio [aOR] 0.44 (95%-CI 0.28-0.70); P<0.001). New onset organ failure occurred in 10.3% versus 4.5% of patients (aOR 0.35 (95%-CI 0.20-0.59); P<0.001). Bleeding occurred in 5.8% versus 5.4% of patients (aOR 0.65 (95%-CI 0.36-1.13); P=0.17). 90-day mortality was 5.0% in the usual care phase (44 patients) versus 2.7% in the post-implementation phase (23 patients; aOR 0.43 (95%-CI 0.20-0.90); P=0.03). Conclusion: Implementation of a multilevel algorithm for early detection and minimally invasive management of complications after pancreatic resection, reduced the composite endpoint of major complications and death. This included a decrease in mortality approximating 50% on a nationwide level.