Randomized Trial of Minimally Invasive Pancreatic Resection

Eligible patients will be recruited at the outpatient clinic. Written informed consent must be provided before inclusion. Included patients will be randomized centrally by the study coordinators (TdR and JvH) using an online randomization module (ALEA, Clinical Research Unit, Academic Medical Center, Amsterdam, the Netherlands) in a 1:1 ratio between MIPD and open pancreatoduodenectomy (Fig. 1). Randomization will be stratified by center to balance differences in surgical procedure and general treatment regimen and by the preoperative probability of developing a postoperative pancreatic fistula: high risk (i.e. pancreatic duct diameter < 3 mm or body mass index > 25 kg/m²) versus low risk (i.e. i.e. pancreatic duct diameter ≥ 3 mm and body mass index ≤ 25 kg/m²). Stratification based on intraoperative patient characteristics was considered impossible. Permuted-block randomization will be used to provide treatment allocation in equal proportions, with block sizes ranging from 2 to 6, subject to random variation. This will be concealed to all investigators involved in the trial.Fig. 1

LEOPARD-2 trial flow diagram according to SPIRIT [36 (link)]. EQ-5D-5 L, Euro-QoL five health dimensions questionnaire; HA, hepatic artery; IC, informed consent; PV, portal vein; QLQ-C30, Quality of life questionnaire including 30 questions; SMA, superior mesenteric artery; SMV, superior mesenteric vein