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    Original Investigation
    February 5, 2020

    Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial

    Author Affiliations
    • 1Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
    • 2Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
    JAMA Surg. Published online February 5, 2020. doi:10.1001/jamasurg.2019.6019
    Key Points

    Question  Is hydrocortisone noninferior compared with pasireotide in reducing pancreatic surgery complications?

    Findings  In this randomized clinical trial that included 126 patients undergoing partial pancreatectomy, the mean Comprehensive Complication Index score (a measurement of overall postoperative morbidity) was –6.16 points lower in patients receiving pasireotide and the lower limit of the 90% CI crossed the prespecified noninferiority margin (–9). In subgroup analyses of patients undergoing distal pancreatectomy, the mean Comprehensive Complication Index score was significantly lower (10.3 points) in the pasireotide vs hydrocortisone group.

    Meaning  In this study, hydrocortisone is not noninferior compared with pasireotide, and pasireotide may be more effective in reducing postoperative complications in patients undergoing distal pancreatectomy.

    Abstract

    Importance  Both hydrocortisone and pasireotide have been shown in randomized clinical trials to be effective in reducing postoperative complications of pancreatic surgery, but to date no randomized clinical trial has evaluated the effectiveness of pasireotide compared with hydrocortisone.

    Objective  To assess the noninferiority of hydrocortisone compared with pasireotide in reducing complications after partial pancreatectomy.

    Design, Setting, and Participants  A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018. Outcome collectors and analyzers were blinded. A total of 281 patients undergoing partial pancreatectomy were assessed for inclusion. Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded. Modified intention-to-treat analysis was used in determination of the results.

    Interventions  Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.

    Main Outcomes and Measures  The primary outcome was the Comprehensive Complication Index (CCI) score within 30 days. The noninferiority limit was set to 9 CCI points.

    Results  Of the 281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses. Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received hydrocortisone (25 men [40%]; median [interquartile range] age, 67 [56-73] years). The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, –6.16; 2-sided 90% CI, –11.73 to –0.60), indicating that hydrocortisone was not noninferior. Postoperative pancreatic fistula was detected in 34 patients (54%) in the pasireotide group and 39 patients (62%) in the hydrocortisone group (odds ratio, 1.39; 95% CI, 0.68-2.82; P = .37). One patient in the pasireotide group and 2 patients in the hydrocortisone group died within 30 days. In subgroup analyses of patients undergoing distal pancreatectomy, the CCI score was a mean of 10.3 points lower (mean [SD], 16.03 [11.94] vs 26.28 [21.76]; 2-sided 95% CI, −19.34 to −2.12; P = .03) and postoperative pancreatic fistula rate was lower (37% vs 67%; P = .02) in the pasireotide group compared with the hydrocortisone group.

    Conclusions and Relevance  In this study, hydrocortisone was not noninferior compared with pasireotide in patients undergoing partial pancreatectomy. Pasireotide may be more effective than hydrocortisone in patients undergoing distal pancreatectomy.

    Trial Registration  ClinicalTrials.gov identifier: NCT02775227; EudraCT identifier: 2016-000212-16

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