UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037533 |
|---|---|
| Receipt number | R000042789 |
| Scientific Title | Affect of surgical margin in perihilar cholangiocarcinoma |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2021/11/19 16:58:55 |
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Basic information
Public title
Affect of surgical margin in perihilar cholangiocarcinoma
Acronym
Affect of surgical margin in perihilar cholangiocarcinoma
Scientific Title
Affect of surgical margin in perihilar cholangiocarcinoma
Scientific Title:Acronym
Affect of surgical margin in perihilar cholangiocarcinoma
Region
| Japan |
Condition
Condition
Perihilar cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate short and long term surgical results of the patiens with perihilar cholangiocarcinoma who had underwent radical surgery on limit of the resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5 year survival rate
Key secondary outcomes
R0 resection rate
Morbidity rate
Mortality rate
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
Perihilar cholagiocarcinoma patients who underwent surgery from 2004 to 2018 in Hokkaido University Hospital Gastroenterological surgery II (or Surgery II)
Key exclusion criteria
1 Unresected patients
2 Surgery for recurrent site
3 HPD cases
4 Resercher's sekection for insufficient for study
Target sample size
212
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University Faculty of Medicine
Division name
Gastroenterological surgery II
Zip code
0608638
Address
Kita15 Nishi7, Kita-ku, Sapporo city
TEL
011-706-7714
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
0608638
Address
Kita15 Nishi 7
TEL
011-706-7714
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Faculty of Medicine, 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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital IRB
Address
Kita14 Nishi5, Kita-ku, Sapporo city
Tel
011-706-7636
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 | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
212
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 | 07 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observation study. Patient's charcteristics (such a gender, age, surgical procedure, operation time, bleeding, morbidity, mortality, R0 resection rate, and survival)
Management information
Registered date
| 2019 | Year | 07 | Month | 29 | Day |
Last modified on
| 2021 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042789
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
