UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030072 |
|---|---|
| Receipt number | R000034337 |
| Scientific Title | Assessment of risk of hepatectomy by liver fibrosis based on MR elastography |
| Date of disclosure of the study information | 2017/11/22 |
| Last modified on | 2017/11/22 01:27:25 |
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Basic information
Public title
Assessment of risk of hepatectomy by liver fibrosis based on MR elastography
Acronym
Assessment of risk of hepatectomy by MR elastography
Scientific Title
Assessment of risk of hepatectomy by liver fibrosis based on MR elastography
Scientific Title:Acronym
Assessment of risk of hepatectomy by MR elastography
Region
| Japan |
Condition
Condition
patients who need hepatctomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective study is to investigate whether LS value determined by MRE is predictive of postoperative major complications (PMCs) after hepatectomy.
Basic objectives2
Others
Basic objectives -Others
postoperative liver failure, evaluated by bio chemical examination and clinical condition.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was Postoperative major complication, defined as Clavian Dindo classification 3a or above.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients scheduled to undergo hepatectomy for any liver disease or liver donation.
Key exclusion criteria
Patients who underwent hepatectomy with resection of other organ or biliary tract or reconstruction of hepatic vein and patientsthose receiving dialysis were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Sato |
Organization
Fukushima medical university
Division name
Hepato-Biliary-Pancreatic and Transplant surgery
Zip code
Address
Hikarigaoka 1, Fukushima
TEL
0245471254
nawoya2U@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoya Sato |
Organization
Fukushima medical university
Division name
Hepato-Biliary-Pancreatic and Transplant surgery
Zip code
Address
Hikarigaoka 1, Fukushima
TEL
0245471254
Homepage URL
nawoya2U@gmail.com
Sponsor or person
Institute
Fukushima medical university
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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 | 11 | Month | 22 | 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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
under analysis
Management information
Registered date
| 2017 | Year | 11 | Month | 22 | Day |
Last modified on
| 2017 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034337
