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
JournalDigestive surgery
DOIs
Publication statusPublished - Jan 1 2019

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Enoxaparin
Venous Thromboembolism
Neoplasms
Hemorrhage
Therapeutics
Safety
Pancreaticoduodenectomy
Information Services
Hepatectomy
Subcutaneous Injections
Registries
Clinical Trials
Incidence

All Science Journal Classification (ASJC) codes

  • Surgery
  • Gastroenterology

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A Prospective, Multi-Center Phase i Study of Postoperative Enoxaparin Treatment in Patients Undergoing Curative Hepatobiliary-Pancreatic Surgery for Malignancies. / Eguchi, Hidetoshi; Kawamoto, Koichi; Tsujie, Masanori; Yukawa, Masao; Kubota, Masaru; Asaoka, Tadafumi; Takeda, Yutaka; Noda, Takehiro; Shimizu, Junzo; Nagano, Hiroaki; Doki, Yuichiro; Mori, Masaki.

In: Digestive surgery, 01.01.2019.

Research output: Contribution to journalArticle

Eguchi, Hidetoshi ; Kawamoto, Koichi ; Tsujie, Masanori ; Yukawa, Masao ; Kubota, Masaru ; Asaoka, Tadafumi ; Takeda, Yutaka ; Noda, Takehiro ; Shimizu, Junzo ; Nagano, Hiroaki ; Doki, Yuichiro ; Mori, Masaki. / A Prospective, Multi-Center Phase i Study of Postoperative Enoxaparin Treatment in Patients Undergoing Curative Hepatobiliary-Pancreatic Surgery for Malignancies. In: Digestive surgery. 2019.
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AU - Tsujie, Masanori

AU - Yukawa, Masao

AU - Kubota, Masaru

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AU - Takeda, Yutaka

AU - Noda, Takehiro

AU - Shimizu, Junzo

AU - Nagano, Hiroaki

AU - Doki, Yuichiro

AU - Mori, Masaki

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