Randomization
PD
BLIND
Patients were randomized on a 1 : 1 basis during surgery by the minimization method (preferred treatment probability 0.9), after resection but before anastomosis, to either PEG-coated patch application (patch group) or no patch (control group). Randomization was done by blocks of 10 patients, using a secure, internet-based, randomization service (RandomizerPatients were assigned to one of the following study groups: patch group, patients undergoing PD with PJ reinforced with two PEG-coated collagen-based haemostatic patches; and control group, patients undergoing PD with PJ without any sealant reinforcement. Although operating-room staff and doctors responsible for the follow-up were not blind to the intervention, data analysis was performed in a masked fashion.