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

研究成果: ジャーナルへの寄稿記事

抄録

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.

元の言語英語
ジャーナルDigestive surgery
DOI
出版物ステータス出版済み - 1 1 2019

Fingerprint

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

これを引用

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.

:: Digestive surgery, 01.01.2019.

研究成果: ジャーナルへの寄稿記事

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. :: Digestive surgery. 2019.
@article{ad350c8a66924fdea7902cfcde0425f4,
title = "A Prospective, Multi-Center Phase i Study of Postoperative Enoxaparin Treatment in Patients Undergoing Curative Hepatobiliary-Pancreatic Surgery for Malignancies",
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.",
author = "Hidetoshi Eguchi and Koichi Kawamoto and Masanori Tsujie and Masao Yukawa and Masaru Kubota and Tadafumi Asaoka and Yutaka Takeda and Takehiro Noda and Junzo Shimizu and Hiroaki Nagano and Yuichiro Doki and Masaki Mori",
year = "2019",
month = "1",
day = "1",
doi = "10.1159/000497451",
language = "English",
journal = "Digestive Surgery",
issn = "0253-4886",
publisher = "S. Karger AG",

}

TY - JOUR

T1 - A Prospective, Multi-Center Phase i Study of Postoperative Enoxaparin Treatment in Patients Undergoing Curative Hepatobiliary-Pancreatic Surgery for Malignancies

AU - Eguchi, Hidetoshi

AU - Kawamoto, Koichi

AU - Tsujie, Masanori

AU - Yukawa, Masao

AU - Kubota, Masaru

AU - Asaoka, Tadafumi

AU - Takeda, Yutaka

AU - Noda, Takehiro

AU - Shimizu, Junzo

AU - Nagano, Hiroaki

AU - Doki, Yuichiro

AU - Mori, Masaki

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85067575734&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85067575734&partnerID=8YFLogxK

U2 - 10.1159/000497451

DO - 10.1159/000497451

M3 - Article

AN - SCOPUS:85067575734

JO - Digestive Surgery

JF - Digestive Surgery

SN - 0253-4886

ER -