UMIN-CTR Clinical Trial

Basic information
Public title	A Multicentral prospective observation study of venous thromboembolism in patient after gastric cancer surgery.
Acronym	An observation study of venous thromboembolism in patient after gastric cancer surgery (SHISA1601)
Scientific Title	A Multicentral prospective observation study of venous thromboembolism in patient after gastric cancer surgery.
Scientific Title:Acronym	An observation study of venous thromboembolism in patient after gastric cancer surgery (SHISA1601)
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the incidence of venous thromboembolism (VTE) by comparison between related facilities and to find the VTE markers for early diagnosis in patients after gastric cancer surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Examination of relationship between venous thromboembolism (VTE) and VTE prevention after gastric cancer surgery
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) histologically diagnosed as gastric cancer 2) planned to receive curative operation 3)ECOG Performance Status Scale: 0-2 4) 20 years old or more at registration 5) Patients who have given oral informed consent to take part in the study after detailed explanation of the study prior to enrollment
Key exclusion criteria	1)Past history of venous thromboembolism till the scheduled date of surgery 2)Severe renal dysfunction (30mL/min >= CCr) 3)Administration of anticoagulant and / or antiplatelet agent before operation 4)Any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study
Target sample size	1120

Research contact person
Name of lead principal investigator	1st name Masaji Middle name Last name Tani
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Tsukinowa-cho, Seta, Otsu, 5202192, JAPAN
TEL	077-548-2238
Email	mtani@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Sachiko Middle name Last name Kaida
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Tsukinowa-cho, Seta, Otsu, 5202192, JAPAN
TEL	077-548-2238
Homepage URL
Email	kaida@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Surgery, Shiga University of Medical Science
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shiga University of Medical Science
Address	Tsukinowa-cho, Seta, Otsu, Shiga
Tel	077-548-2238
Email	kaida@belle.shiga-med.ac.jp

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	滋賀医科大学医学部附属病院（滋賀県）、草津総合病院（滋賀県）、ベルランド総合病院（大阪府）、長浜赤十字病院（滋賀県）、奈良市立病院（奈良県）、小松市民病院（石川県）、新古賀病院（福岡県）、赤穂市民病院（兵庫県）、古賀病院21（兵庫県）、JCHO滋賀病院（滋賀県）、畷生会脳外科病院（大阪府）、日野記念病院（滋賀県）、豊郷病院（滋賀県）、甲南病院（滋賀県）、野洲病院（滋賀県）、湖東記念病院（滋賀県）、琵琶湖大橋病院（滋賀県）、喜馬病院（大阪府）、西京都病院（京都府）、マキノ病院（滋賀県）、紫香楽病院（滋賀県）、長浜市立湖北病院（滋賀県）、生田病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2023 Year 06 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: Observation study Object recruitment : All patients who admitted in Shiga University of Medical Science or other related facility and meet the selection criteria from June 1,2016 to May 28, 2018. Parameter measurement: The following results of blood test on the preoperative day and the postoperative day 7: complete blood count(CBC), Albumin, ALT, AST, T-Bil, Cre, PT, APTT, D-dimer

Management information
Registered date	2016 Year 03 Month 31 Day
Last modified on	2022 Year 05 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025038