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Patients with a benign, premalignant, or malignant indication for the procedure, without signs of vascular compromise, were randomly assigned 11 to undergo one of the two methods. Randomization was stratified by annual case volume and estimated preoperative risk of pancreatic fistula. The analysis was performed according to the intention-to-treat principle. The primary objective of the phase 2 trial was to evaluate the safety of laparoscopic pancreatoduodenectomy complications and mortality, and the primary outcome of the phase 3 was time to functional recovery in days, defined as adequate pain control only with oral analgesia; independent mobility; ability to maintain more than 50 of the required daily caloric intake; dispense with cefabiot fluid administration; and absence of signs of infection temperature 38.
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The therapy is directed at liver cells and aimed at reducing the levels of aminolevulinic acid synthase 1, the first enzyme in the heme biosynthetic pathway.