A Prospective, Multi-Center Phase i Study of Postoperative Enoxaparin Treatment in Patients Undergoing Curative Hepatobiliary-Pancreatic Surgery for Malignancies

Hidetoshi Eguchi, Koichi Kawamoto, Masanori Tsujie, Masao Yukawa, Masaru Kubota, Tadafumi Asaoka, Yutaka Takeda, Takehiro Noda, Junzo Shimizu, Hiroaki Nagano, Yuichiro Doki, Masaki Mori

Research output: Contribution to journalArticle

Abstract

Background: Venous thromboembolism (VTE) is one of the critical complications that can occur after surgery. A positive association between cancer and VTE risk is well established; however, the safety and efficacy of VTE prophylaxis have not been established in hepatobiliary-pancreatic surgery, especially in surgery for malignancies. Methods: A prospective, multi-center Phase I study to determine the safety of enoxaparin was performed. Subcutaneous injection of enoxaparin was initiated 48-72 h after surgery and repeated for 8 days. The primary endpoint was the incidence of bleeding events. This study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000007761). Results: A total of 154 patients was registered and 133 patients including 74 hepatectomies and 35 pancreaticoduodenectomies were analyzed. Three patients (2.3%) exhibited major bleeding events postoperatively, while 7 (5.2%) had minor bleeding. No Symptomatic VTE was observed. Conclusions: Our study indicated that enoxaparin was well tolerated and safe for patients who received hepatobiliary-pancreatic surgery for malignancies.

Original languageEnglish
Pages (from-to)81-86
Number of pages6
JournalDigestive surgery
Volume37
Issue number1
DOIs
Publication statusPublished - Jan 1 2020

All Science Journal Classification (ASJC) codes

  • Surgery
  • Gastroenterology

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    Eguchi, H., Kawamoto, K., Tsujie, M., Yukawa, M., Kubota, M., Asaoka, T., Takeda, Y., Noda, T., Shimizu, J., Nagano, H., Doki, Y., & Mori, M. (2020). A Prospective, Multi-Center Phase i Study of Postoperative Enoxaparin Treatment in Patients Undergoing Curative Hepatobiliary-Pancreatic Surgery for Malignancies. Digestive surgery, 37(1), 81-86. https://doi.org/10.1159/000497451