Hydrocortisone vs. pasireotide in preventing pancreatic surgery complications - prospective randomized controlled trial

Abstract

Background: Pancreatic surgery has high rate of complications and most complications are due to postoperative pancreatic fistula (POPF). Both hydrocortisone (Laaninen et al., J Ann Surg 2016) and pasireotide (Allen et al., NEJM 2014) has been showed to reduce POPF compared to placebo. This trial was set to find out whether these two drugs are equally efficient or not. Materials and Methods: In this study only the patients with high risk of POPF (soft gland texture and normal pancreatic duct in patients undergoing pancreaticoduodenectomy, all distal pancreatectomies and enucleations) were included and randomized in 1:1 ratio to receive perioperatively either hydrocortisone or pasireotide. Primary outcome was comprehensive complication index (CCI) 30 days postoperatively. Key secondary outcomes were rate of POPF and death. This was a non-inferiority trial, and difference larger than 10 CCI points was considered significant. Based on the sample size calculation 124 patients were needed to be randomized. Treating physicians, outcome assessors, data collectors, and data analysts were blinded to the assigned group. For interrim analysis, groups were assigned labels A or B, without knowing which label was which group. Results: The recruiting was stopped on 17th December 2018 after reaching the aimed sample size, and thus 30-day outcome is not yet assessable. An interrim analysis was performed in December 2017 when 64 patients were enrolled, and the 30-day follow up data was gathered. In group A, mean CCI was 23.3 and in group B 28.1 (difference -4.72 (95% CI -14.9 - -5.5)). The ratio of clinically relevant POPFs (grade B/C) were equal (19% vs. 16%). One patient died in both groups. Conclusions: Rates of complications, POPF and death were similar between the groups in interrim analysis, but non-inferiority was not yet demostrated. The final Results will be presented at the E-AHPBA Congress.