1. Randomized, controlled, multi-center phase II study of postoperative enoxaparin treatment for venous thromboembolism prophylaxis in patients undergoing surgery for hepatobiliary-pancreatic malignancies.
- Author
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Shinke G, Takeda Y, Ohmura Y, Kobayashi S, Wada H, Morimoto O, Tomokuni A, Shimizu J, Asaoka T, Tanemura M, Noda T, Doki Y, and Eguchi H
- Abstract
Purpose: Postoperative venous thromboembolism (VTE) risk is pronounced after abdominal cancer surgery. Enoxaparin shows promise in preventing VTE in gastrointestinal, gynecological, and urological cancers, but its application after surgery for hepatobiliary-pancreatic malignancy has been under-evaluated due to bleeding concerns. We confirmed the safety of enoxaparin administration in patients undergoing curative hepatobiliary-pancreatic surgery for malignancies in a prospective, multi-center, phase I study., Methods: The study was conducted from April 2015 to May 2021 across eight specialized centers. Patients ( n = 262) were randomized to enoxaparin prophylaxis given postoperatively for 8 days ( n = 131) or control ( n = 131). The primary endpoint was the efficacy in reducing VTE. Secondary endpoints examined safety., Results: The full analysis set included 259 patients (131 control, 129 enoxaparin). The per-protocol population included 233 patients (117 control, 116 enoxaparin). Most cases were hepatic malignancies (111 control, 111 enoxaparin). The median administration duration of enoxaparin was 7 days, with 92% receiving 4000 units/day. Despite a reduction in the relative risk (RR) of VTE due to postoperative enoxaparin administration, the results were not significant (control: four cases, 3.4% vs. treatment: two cases, 1.7%; RR 0.50, 95% CI 0.09-2.70; p = 0.6834). No significant difference was found in the incidence of bleeding events (control: five cases, 4.3% vs. treatment: five cases, 4.3%, RR 1.00, 95% CI 0.53-1.89; p = 1.0000)., Conclusions: The perioperative administration of enoxaparin in hepatobiliary-pancreatic malignancies is feasible and safe. However, further case accumulation and investigation are necessary to assess its potential in reducing the occurrence of VTE., Competing Interests: Yuichiro Doki is an editorial board member of Annals of Gastroenterological Surgery. Other authors declare no conflicts of interest for this article., (© 2024 The Authors. Annals of Gastroenterological Surgery published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Gastroenterological Surgery.)
- Published
- 2024
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