UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013080 |
|---|---|
| Receipt number | R000015243 |
| Scientific Title | Pathological Characteristics of intraductal papillary neoplasm of the bile duct |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2023/02/18 15:41:49 |
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Basic information
Public title
Pathological Characteristics of intraductal papillary neoplasm of the bile duct
Acronym
Pathological Characteristics of intraductal papillary neoplasm of the bile duct
Scientific Title
Pathological Characteristics of intraductal papillary neoplasm of the bile duct
Scientific Title:Acronym
Pathological Characteristics of intraductal papillary neoplasm of the bile duct
Region
| Japan |
Condition
Condition
Intraductal papillary neoplasm of bile duct
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Intraductal papillary neoplasm of bile duct(IPNB) is discribed in WHO classification (2010).IPNB is a counterpart of IPMN in pancreas. The immunohistopathological subtypes based on that of IPMN may be related to the malignant potential or prognosis . We clarify the correlation between histopathological findings and malignant potential/prognosis.
Basic objectives2
Others
Basic objectives -Others
To clarify biological and clinical characteristics of intraductal papillary neoplasm of bile duct(IPNB).
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between histopathological findings and malignant potential/prognosis
Key secondary outcomes
Characteristics of the histopathological findings
Clinical characteristics of IPNB
Prognosis
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
1)From 1993 to 2018
2)All of the patients who had diagnosed intraductal papillary neoplasm of bile duct based on the pathological findings.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryusei Matsuyama |
Organization
Yokohama City University, School of Medicine
Division name
Department of Gastroenterological surgery
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045-787-2650
fummy0502@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumi Harada |
Organization
Yokohama City University, School of Medicine
Division name
Department of Gastroenterological surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa, Japan
TEL
045-787-2650
Homepage URL
fummy0502@gmail.com
Sponsor or person
Institute
Yokohama City University, School of Medicine, Department of Gastroenterological surgery
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
None
Name of secondary funder(s)
None
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
横浜市立大学医学部 消化器腫瘍外科学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
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 | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2014 | Year | 02 | Month | 05 | Day |
Last modified on
| 2023 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015243
