Preconditioning with hyperbaric oxygen in pancreaticoduodenectomy: a randomized, double-blind pilot study A. Casarotto#*MD; G. Bosco€ MD; E. Nasole$ MD; M. Camporesi MD PhDφ; R. Salvia MD PhD#; F. Giovinazzo#* MD PhD; S. Zanini* PhD; G. Malleo# MD; A. Di Tano MD PhD°; D. Mangar MD& and C. Bassi#* MD FACS FRCS . € Department of Biomedical Science – Laboratory of Phisiology, University of Padova, Via Marzolo 3, IT 35131 Padova, Italy.ATIp, Hyperbaric Medical Center, Via Cornaro 1, Padova, Italy. # Surgical Department, Istituto del Pancreas, Hospital ‘G.B. Rossi’, University of Verona, Piazzale ‘LA. Scuro’, IT-37134 Verona, Italy. $ φ Hyperbaric Institute SpA Via Francia, 35, IT- 37069 Villafranca Verona, Italy. Department of Surgery/Anesthesiology, University of South Florida, Tampa, Florida, USA. * Laboratory of Translational Surgery. University Laboratory for Medical Research-Verona (L.U.R.M), University of Verona, Piazzale ‘L.A. Scuro’, IT37134 Verona, Italy. ° Department of basic and applied medical sciences, University of Chieti, Via dei Vestini, 66100 Chieti, Italy. & FGTBA LLC Tampa , FL 33606, USA. Abstract In abdominal surgery, pancreaticoduodenectomy (PD) represents the intervention mostly burdened by various local and systemic complications. In this study we evaluated post-operative biological and clinical effects of a single preoperative hyperbaric treatment the day before surgery for pancreatic ductal adenocarcinoma. The study was a prospective randomized single-blind study lasting 6 months in 21 patients (10 [group-A;47.6%], HBO-group and 11 [group-B;52.4%], placebo-group). Patients were randomized and divided into two groups: group-A was submitted to a HBO session the day before PD intervention. Group-B patients breathed air for 40 minutes in a hyperbaric chamber pressurized to 1.15 ATA. In all patients blood samples were taken before HBO treatment or placeboprocedure (T0), at the end of HBO session or placebo-procedure (T1), on the first post-operative day (POD) (T2) and on seventh POD (T3). We measured interleukin (IL)-1,IL-6,IL-8,IL-10,IL-12p70 and TNF-α. Adverse outcomes that were recorded included postoperative pancreatic fistula (POPF), biliary fistula, fever, intra abdominal abscess, bleeding, pulmonary complications, delayed gastric emptying and requirement for post-operative antibiotics. Compared with Group B, patients in Group A had fewer postoperative pulmonary infections (0/10 in group A vs 6/11 group B, p=0.023). HBO-PC modulates IL-6 synthesis (p=0.009) and IL-10 one (p=0.03), and does not cause more bleeding compared to placebo (p = 0.450). There was a statistically significant relationship between IL-6 and biliary fistula (p=0.009). IL-1 (p=0.006) and TNF-α (p=0.04) were correlated with hyperpyrexia. TNF-α levels were related to POPF (p=0.019). The results of this pilot study suggest that a single preoperative hyperbaric oxygen treatment on the day before surgery may reduce the complication rate in pancreatic resection.