UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010416 |
|---|---|
| Receipt number | R000012186 |
| Scientific Title | Role of Bile Duct Resection in Major Hepatectomyy due to Intrahepatic Cholangiocarcinoma (KHBO1206) |
| Date of disclosure of the study information | 2013/04/06 |
| Last modified on | 2019/12/25 16:28:07 |
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Basic information
Public title
Role of Bile Duct Resection in Major Hepatectomyy due to Intrahepatic Cholangiocarcinoma (KHBO1206)
Acronym
Role of Bile Duct Resection in Major Hepatectomyy due to Intrahepatic Cholangiocarcinoma (KHBO1206)
Scientific Title
Role of Bile Duct Resection in Major Hepatectomyy due to Intrahepatic Cholangiocarcinoma (KHBO1206)
Scientific Title:Acronym
Role of Bile Duct Resection in Major Hepatectomyy due to Intrahepatic Cholangiocarcinoma (KHBO1206)
Region
| Japan |
Condition
Condition
intrahepatic cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prognosis due to presence or absence of bile duct resection in intrahepatic cholangiocarcinoma that require hepatic lobectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) 3-year recurrence-free survival rate
2) initial recurrence site
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
Cases of major hepatectomy due to intrahepatic cholangiocarcinoma
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagano |
Organization
Osaka University, Graduate School of Medicine
Division name
Surgery
Zip code
Address
Yamadaoka 2-2, Suita city, Osaka, JAPAN
TEL
06-6879-3251
s-kobayashi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Kobayashi |
Organization
Osaka University, Graduate School of Medicine
Division name
Surgery
Zip code
Address
Yamadaoka 2-2, Suita city, Osaka, JAPAN
TEL
81729212012
Homepage URL
s-kobayashi@umin.ac.jp
Sponsor or person
Institute
Kansai Hepatobiliary Oncology Group (KHBO)
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 04 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2013 | Year | 04 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012186
