UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027567 |
|---|---|
| Receipt number | R000031603 |
| Scientific Title | Intraductal papillary neoplasm of the bile duct found incidentally during examination of colonic disease: A case report |
| Date of disclosure of the study information | 2017/06/15 |
| Last modified on | 2017/05/31 14:01:41 |
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Basic information
Public title
Intraductal papillary neoplasm of the bile duct found incidentally during examination of colonic disease: A case report
Acronym
Intraductal papillary neoplasm of the bile duct found incidentally during examination of colonic disease: A case report
Scientific Title
Intraductal papillary neoplasm of the bile duct found incidentally during examination of colonic disease: A case report
Scientific Title:Acronym
Intraductal papillary neoplasm of the bile duct found incidentally during examination of colonic disease: A case report
Region
| Japan |
Condition
Condition
Intraductal papillary neoplasm of the bile duct
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
one patient
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We are report a relatively rare case of IPNB. Although preoperative diagnosis of IPNB remains challenging, curative resection is the major treatment and an important factor in determining long-term survival.
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
| 54 | years-old | <= |
Age-upper limit
| 54 | years-old | >= |
Gender
Male
Key inclusion criteria
none
Key exclusion criteria
none
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Tomofuji |
Organization
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
+81335200111
xk62h.ykatsuz57@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Tomofuji |
Organization
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
+81335200111
Homepage URL
xk62h.ykatsuz57@gmail.com
Sponsor or person
Institute
None declared
Institute
Department
Personal name
Funding Source
Organization
None declared
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2017 | Year | 06 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case report
Management information
Registered date
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031603
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
