UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014580 |
|---|---|
| Receipt number | R000016960 |
| Scientific Title | The study for the relation of FXIII activity with intraoperative bleeding and morbidity in hepatobiliary surgery. |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2019/07/21 16:18:00 |
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Basic information
Public title
The study for the relation of FXIII activity with intraoperative bleeding and morbidity in hepatobiliary surgery.
Acronym
The study for the relation of FXIII activity with intraoperative bleeding.
Scientific Title
The study for the relation of FXIII activity with intraoperative bleeding and morbidity in hepatobiliary surgery.
Scientific Title:Acronym
The study for the relation of FXIII activity with intraoperative bleeding.
Region
| Japan |
Condition
Condition
Patients who are going to undergo hepatic lobectomy or pancreaticoduodenectomy (irrespective of disease type)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis as the following;
Perioeprative deterioration of factor XIII activity leads to an increased intraoperative bleeding and incidence of postoperative complications.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between the activity of factor XIII and intraoperative bleeding, intra/postoperative blood transfusion.
Key secondary outcomes
The association between the activity of factor XIII and postoperative liver failure, bile leakage, pancreatic fistula, anastomotic failure, and infectious complications.
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) patients age at 20 or more
2) patients who undergo hepatic lobectomy or pancreaticoduodenectomy (irrespective of disease).
3) patients who agreed to participate this study
Key exclusion criteria
1) patients who refused to participate this study
2) patients who are not eligible to participate this study (by the decision of responsible physician)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Hospital
Division name
Surgery 1
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2222
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Division of Surgical Oncology, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Division of Surgical Oncology, Department of Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Institutional Review Board
Address
65 Tsurumai-cho, Showa-ku
Tel
+81527442222
ethics@med.nagoya-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
| 2014 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
not applicable
Publication of results
Published
Result
URL related to results and publications
not applicable
Number of participants that the trial has enrolled
43
Results
Unexpectedly high proportions of patients undergoing pancreatoduodenectomy had low preoperative FXIII activities. Preoperative FXIII deficiency may increase intraoperative bleeding but had no influence on the postoperative outcomes.
Results date posted
| 2019 | Year | 07 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who are going to undergo pancreatoduodenectomy
Participant flow
All patients who are going to undergo pancreatectomy, fit to inclusion criteria, and consented to participate the study were enrolled.
Adverse events
none
Outcome measures
intraoperative blood loss and postoperative complications
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before starting the study
Management information
Registered date
| 2014 | Year | 07 | Month | 17 | Day |
Last modified on
| 2019 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016960
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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