Tri-Staple vs Ultrasonic Scalpel in Distal Pancreatectomy (TRUDY). A randomized controlled, multicenter, patient blinded, superiority trial

Background: Several systematic reviews have investigated pancreatic stump management to reduce the postoperative pancreatic fistula (POPF) rate. The study aimed to evaluate if the parenchymal transection using the triple-row reinforced stapler decreases the incidence of POPF compared with ultrasonic transection after distal pancreatectomy (DP). Methods: a bicentric, phase 3, patient-blinded, randomized clinical trial was conducted. All patients submitted to elective DP from July 2018 through July 2020 were screened. Exclusion criteria were an extended resection, gastrointestinal resections or anastomoses, and a pancreatic thickness >17 mm measured at the point of parenchymal transection. The experimental group received the Endo GIA Reinforced Reload with Tri-Staple Technology (TS), while the control group the Harmonic Focus (US). Results:A total of 152 patients undergoing DP met the inclusion criteria and were randomized. Due to a positive transection margin on frozen section analysis requiring further resection, seven patients were excluded post-randomization. Therefore, the final population comprised 72 patients in the TS arm and 73 patients in the US arm. Overall, 23 patients (16%) developed POPF. There were 19 grade B (14%) and 4 grade C fistulas (2%). The incidence of POPF was similar between groups (TS 12% vs. US 19%, p=0.191). Conclusion: the present randomized controlled trial of stapled transection using a PGA-reinforced triple-row stapler versus ultrasonic transection with HARMONIC energy devices in elective DP demonstrated no significant difference in POPF rates.