Optimal prophylactic method of venous thromboembolism for gastrectomy in Korean patients: Prospective randomized controlled trial.

Authors

null

Yoon Ju Jung

The Catholic University of Korea, Seoul, Republic of Korea

Yoon Ju Jung , Kyo Young Song , Ho Seok Seo , Cho Hyun Park

Organizations

The Catholic University of Korea, Seoul, Republic of Korea, Division of Gastrointestinal Surgery, Department of Surgery, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea, Division of Gastrointestinal Surgery, Department of Surgery, College of Medicine, The Catholic University of Korea, Seoul, Korea, Seoul, Republic of Korea, The Catholic University of Korea, Seoul, South Korea

Research Funding

Pharmaceutical/Biotech Company

Background: This study was conducted to evaluate the incidence of VTE after surgery gastric cancer patients and determined the optimal method of thromboembolic prophylaxis in Korean patients. Methods: In this trial, 682 patients were assigned to 2 groups; an intermittent pneumatic compression (IPC) with or without 40 mg of enoxaparin. The primary outcome was VTE incidence within 30 days of surgery; defined as deep vein thrombosis (DVT) or documented pulmonary thromboembolism (PTE). The duration of follow-up was 6 months. Results: The primary outcome was assessed in 666 patients. The overall incidence of VTE was 2.10%; that of IPC group was significantly higher than the IPC plus enoxaparin group. Among 14 patients with VTE; 13(92.8%) patients were diagnosed with asymptomatic DVT, 1 patient was diagnosed with PTE. The incidence of bleeding complication was significantly higher in IPC plus enoxaparin group. By month 6, no patient died. Conclusions: Although the incidence of VTE was significantly lower in IPC plus enoxaparin group, symptomatic event was extremely rare and no mortality was observed. In Korean patient with gastric cancer does not need conventional prophylaxis using heparin because of the extremely lower incidence of symptomatic VTE and relatively higher incidence of bleeding complication. Clinical trial information: NCT01448746

Total
(N = 666)
IPC
(n = 336)
IPC+heparin
(n = 330)
DVT detected by DUS, no14122
DVT detected by symptom or sign, no000
PTE detected, no110
VTE rate (95 % CI)2.10 (1.26-3.50)3.57 (2.05-6.14)0.61 (1.07-2.18)

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Abstract Details

Meeting

2017 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Cancers of the Esophagus and Stomach

Track

Cancers of the Esophagus and Stomach

Sub Track

Prevention, Diagnosis, and Screening

Clinical Trial Registration Number

NCT01448746

Citation

J Clin Oncol 35, 2017 (suppl 4S; abstract 7)

DOI

10.1200/JCO.2017.35.4_suppl.7

Abstract #

7

Poster Bd #

D7

Abstract Disclosures