UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031043 |
|---|---|
| Receipt number | R000035454 |
| Scientific Title | Impact of tumor localization on the outcomes of surgery for an intrahepatic cholangiocarcinoma |
| Date of disclosure of the study information | 2018/01/30 |
| Last modified on | 2018/08/01 11:40:49 |
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Basic information
Public title
Impact of tumor localization on the outcomes of surgery for an intrahepatic cholangiocarcinoma
Acronym
Impact of tumor localization on the outcomes of surgery for an intrahepatic cholangiocarcinoma
Scientific Title
Impact of tumor localization on the outcomes of surgery for an intrahepatic cholangiocarcinoma
Scientific Title:Acronym
Impact of tumor localization on the outcomes of surgery for an intrahepatic cholangiocarcinoma
Region
| Japan |
Condition
Condition
Intrahepatic cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the clinicopathological features and surgical outcomes of hilar type intrahepatic cholangiocarcinoma and peripheral type intrahepatic cholangiocarcinoma.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year survival rate
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Intrahepatic cholangiocarcinoma patients who underwent several types of hepatectomy at the Department of Gastroenterological Surgery I at Hokkaido University Hospital between 1987 to 2017.
Key exclusion criteria
Liver disease other than intrahepatic cholangiocarcinoma
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Orimo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery I
Zip code
Address
North 15-West 7, Kita-Ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-5927
tatsuori@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Orimo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery I
Zip code
Address
North 15-West 7, Kita-Ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-5927
Homepage URL
tatsuori@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School of Medicine
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
| 2018 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29721628
Number of participants that the trial has enrolled
Results
HICC shows more frequent bile duct invasion and lymph node metastasis, requires more extensive surgery, and has a higher rate of non-curative resection than PICC. However, if curative resection is achieved, the survival outcomes are expected to be equivalent between HICC and PICC.
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
| 1987 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1987 | Year | 01 | 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
HICC shows more frequent bile duct invasion and lymph node metastasis, requires more extensive surgery, and has a higher rate of non-curative resection than PICC. However, if curative resection is achieved, the survival outcomes are expected to be equivalent between HICC and PICC.
Management information
Registered date
| 2018 | Year | 01 | Month | 29 | Day |
Last modified on
| 2018 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035454
