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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027919
Receipt No. R000029409
Scientific Title Impact of antithrombotic agent on the clinical course after pancreatectomy
Date of disclosure of the study information 2017/08/01
Last modified on 2017/06/22

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

Public contact
1st name of contact person
1st name
Middle name
Last name Kota Nakamura
Organization Nara Medical University
Division name Department of Surgery
Zip code
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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 05 Day
Last follow-up date
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
2017 Year 06 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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