1. Hydrocortisone is not noninferior to pasireotide in the reduction of postoperative complications in patients undergoing distal pancreatectomy.
Evidence Rating: 1 (Excellent)
Partial pancreatectomies carry high risk profile for complications, with pancreatic fistulas being one of the major sources of serious postoperative complications. Despite various alterations to surgical methodology and pharmacologic therapies being suggested, the risk of a clinically significant pancreatic fistula being developed postoperatively remains as high as up to one-third of patients receiving the treatment. Perioperative hydrocortisone and pasireotide, a somatostatin analog, have been suggested by previous research to be two pharmacologic agents that are effective in preventing perioperative fistula, though no investigations have formally compared the efficacy of the two. In this noninferiority, parallel-group, individually randomized clinical trial conducted at an academic center between May 2016 to December 2018, 281 patients undergoing partial pancreactectomy were randomly assigned to receive either perioperative pasireotide or hydrocortisone as treatment. Rates of pancreatic fistula development and the Comprehensive Complication Index (CCI) score, a measure taking into account all cumulative complications from an operation, were used as study outcome measures. The hydrocortisone group mean (SD) CCI score was 30.11(20.47) compared to the pasireotide group’s mean of 23.94 (17.06), not meeting the predetermined noninferiority limit of 9 CCI points. Fistulas were detected in 54% of patients in the pasireotide group and 62% in the hydrocortisone group (odds radio, 1.39. 95% CI, 0.68-2.82; p = .37). Further subgroup analysis of patients undergoing distal pancreatectomy revealed a significantly lower CCI score and significantly lower rates of pancreatic fistula formation in the pasireotide group versus the hydrocortisone group. Study results did not reinforce previous findings that put forth hydrocortisone as a potentially noninferior, more cost-effective alternative to pasireotide for postoperative care in patients receiving pancreatectomy.
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