UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027919 |
|---|---|
| Receipt number | 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 | 2021/06/28 09:34:31 |
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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
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
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
knaka@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029409
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
