UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036316 |
|---|---|
| Receipt number | R000041357 |
| Scientific Title | The relationship between waiting time after preoperative portal vein embolism and mortality with hepatic failure in perihilar cholangiocarcinoma patients |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2020/06/24 09:28:21 |
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Basic information
Public title
The relationship between waiting time after preoperative portal vein embolism and mortality with hepatic failure in perihilar cholangiocarcinoma patients
Acronym
Evaluation of wating time after portal vein embolization
Scientific Title
The relationship between waiting time after preoperative portal vein embolism and mortality with hepatic failure in perihilar cholangiocarcinoma patients
Scientific Title:Acronym
Evaluation of wating time after portal vein embolization
Region
| Japan |
Condition
Condition
Perihilar cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate relation between pre operative poral vein embolization (pre PE) and post operative liver failure, mortality. And also evaluate relation between wating time after pre PE and post operative complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
90days mortality
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with perihilar cholangiocarcinoma who underwent surgery in Hokkaido University hospital department of gastroenterological surgery II from January 1st 2000 to December 31 2018.
Key exclusion criteria
Without agreement for attendance
Target sample size
222
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University hospital
Division name
Gastroenterological surgery II
Zip code
060-8638
Address
Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido Japan
TEL
0117067714
drnoji@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University Faculty of Medicine
Division name
Gastroenterological surgery II
Zip code
060-8638
Address
Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido Japan
TEL
0117067714
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital, Gastroenterological surgery II
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Hokkaido University Faculty of Medicine
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
HokkaidonUniversity Hospital IRB
Address
kita 14 Nishi 5, Kita-ku, Sapporo city
Tel
0117161161
crjimu@huhp.hokudai.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
| 2019 | 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
183
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
| 2019 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate patietnt's characteristics and surigical outcome, retrospectively.
Management information
Registered date
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2020 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041357
| 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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