UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory Clinical Trial for Efficacy and Safety of Short-term (3 days) Enoxaparin on Prevention of Venous Thromboembolism after Gastric Cancer Surgery
Title of the study (Brief title)	Efficacy and Safety of Short-term (3 days) Enoxaparin on Gastric Cancer Surgery
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of 3-day use of low molecular weight heparin (enoxaparin) combined with intermittent pneumatic compression on prevention of postoperative venous thromboembolism for gastric cancer patients over 40 years of age who are planned to receive gastrectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of venous thromboembolism at 8 to 14 days after surgery
Key secondary outcomes	Incidence of bleeding-related adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Subcutaneous injection of enoxaparin (2000IU, twice a day, from night of the 1st day to morning of the 4th day, 6 times in total) in combination with intermittent pneumatic compression
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with histologically-diagnosed gastric cancer who are planned to receive total, distal, proximal or partial gastrectomy (surgical approach do not matter) 2) Patients over 40 years of age 3) Patients who can give written informed concent
Key exclusion criteria	1) Patients with past history of venous thromboembolism 2) Patients with past history of allergic reaction to heparin or heparinoid (including low molecular weight heparin) 3) Patients with active bleeding (except for bleeding from gastric cancer planned to be resected by surgery) 4) Patients with acute bacterial endocarditis 5) Patients with severe renal dysfunction (Ccr < 30mL/min) 6) Patients with past history of heparin-induced thrombocytopenia 7) Patients who are otherwise judged by the investigator as unsuitable for enrollment
Target sample size	70

Research contact person
Name of lead principal investigator	Toshiyoshi Fujiwara
Organization	Okayama University
Division name	Gastroenterological Surgery
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7257
Email	toshi_f@md.okayama-u.ac.jp

Public contact
Name of contact person	Shinji Kuroda
Organization	Okayama University
Division name	Gastroenterological Surgery
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7257
Homepage URL
Email	shinkuro@okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Gastroenterological Surgery, Okayama University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 15 Day
Anticipated trial start date	2016 Year 03 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 16 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023369