UMIN-CTR Clinical Trial

Basic information
Public title	Impact of antithrombotic agent on the clinical course after pancreatectomy
Acronym	Impact of antithrombotic agent on the clinical course after pancreatectomy
Scientific Title	Impact of antithrombotic agent on the clinical course after pancreatectomy
Scientific Title:Acronym	Impact of antithrombotic agent on the clinical course after pancreatectomy
Region	Japan

Condition
Condition	perioperative complication
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to clarify the effect of antithrombotic agent on the clinical course after pancreatectomy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of postpancreatectomy hemorrhage during the same hospitalization.
Key secondary outcomes	incidence of post operative thrombotic disease during the same hospitalization, intraoperative characteristics(duration of surgery, intraoperative blood loss, rate of transfusion, postoperative hospital stay), incidence of surgical complications (pancreatic fistula, delayed gastric emptying, abdominal abscess) during the same hospitalization, mortality during the same hospitalization or with in 30 days after surgery.

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	Patients underwent pancreatectomy at Nara Medical University or Kansai medical university Between 2007, and 2016.
Key exclusion criteria	Rejection for participating in the study
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Kota Middle name Last name Nakamura
Organization	Nara Medical University
Division name	Department of Surgery
Zip code	6348521
Address	840 Shijo-cho, Kashihara, Nara, JAPAN
TEL	0744-22-3051
Email	knaka@naramed-u.ac.jp

Public contact
Name of contact person	1st name Kota Middle name Last name Nakamura
Organization	Nara Medical University
Division name	Department of Surgery
Zip code	6348521
Address	840 Shijo-cho, Kashihara, Nara, JAPAN
TEL	0744-22-3051
Homepage URL
Email	knaka@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nara Medical University
Address	840 Shijo-cho, Kashihara, Nara, JAPAN
Tel	0744-22-3051
Email	knaka@naramed-u.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

Other administrative information
Date of disclosure of the study information	2017 Year 08 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	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
Date of IRB	2016 Year 12 Month 19 Day
Anticipated trial start date	2017 Year 01 Month 05 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	There are neither duration of intervention nor observation in this study because this study is retrospective study in which the data of patients who underwent pancreatectomy are picked up from medical records.

Management information
Registered date	2017 Year 06 Month 25 Day
Last modified on	2021 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029409