UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022933 |
|---|---|
| Receipt number | R000026432 |
| Scientific Title | A Japan-South Korea joint research project on intraductal papillary tumour, mucinous cystic tumour or neoplasm, and papillary bile duct carcinoma |
| Date of disclosure of the study information | 2016/09/30 |
| Last modified on | 2016/06/28 21:56:22 |
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Basic information
Public title
A Japan-South Korea joint research project on intraductal papillary tumour, mucinous cystic tumour or neoplasm, and papillary bile duct carcinoma
Acronym
A Japan-South Korea joint research project on intraductal papillary tumour, mucinous cystic tumour or neoplasm, and papillary bile duct carcinoma
Scientific Title
A Japan-South Korea joint research project on intraductal papillary tumour, mucinous cystic tumour or neoplasm, and papillary bile duct carcinoma
Scientific Title:Acronym
A Japan-South Korea joint research project on intraductal papillary tumour, mucinous cystic tumour or neoplasm, and papillary bile duct carcinoma
Region
| Japan | Asia(except Japan) |
Condition
Condition
intraductal papillary neoplasm of the bile duct, mucinous cystic tumour or neoplasm, and papillary bile duct carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To register a large-scale data collection project implemented jointly by Japan and South Korea through the Japan Biliary Association, the South Korea Biliary Association, and the South Korean Society of Hepato-Biliary-Pancreatic Surgery. To further elucidate the pathogenesis of IPNB and MCN, and to examine pathological differences between IPNB and papillary bile duct carcinoma. In addition, to examine the validity of the new morphological classification of IPNB, and collect images and prognostic information for a large number of cases
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cases of intraductal papillary neoplasm of the bile duct, mucinous cystic tumour or neoplasm, and papillary bile duct carcinoma are coded so that individual patients cannot be identified and personal information is protected. Subsequently, data are registered into a large-scale Japan-South Korea joint database. Details of the registered data are described below.
[Registered data]
Name of the hospital, preoperative diagnosis, sex, age, height, weight, presence or absence of smoking, presence or absence of drinking, biochemical laboratory findings (CEA, CA19-9, DUPAN-2, WBC, RBC, Plt, Hb, ALT, AST, LDH, ganma-GTP, ALP, T-bil, D-bil, CRP, TG, and Tcho), detailed pathological findings regarding the intraductal papillary neoplasm of the bile duct, mucinous cystic tumour or neoplasm, and papillary bile duct carcinoma (localization of the cystic lesions, maximum diameter, and presence of any communication between the cysts and the bile duct), date of surgery, operative procedure, pathological findings (lymph node metastasis, portal vein invasion, hepatic vein invasion, hepatic artery invasion, bile duct invasion, and liver and duodenum bile duct stump findings) relapse date, final diagnosis date, date and time of death, etc.
An Excel file with the above data is sent, and responses are entered using a pull-down list. Once responses are completed, the file is returned, and data are analysed. Haematoxylin and eosin-stained and immune-stained thin sections are prepared and submitted, so that pathological specimens can be examined by two pathologists (N.Y.,F.T.and T.F.)
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 intraductal papillary neoplasm of the bile duct, mucinous cystic tumour or neoplasm, and papillary bile duct carcinoma in Japan and South Korea
Key exclusion criteria
Non-consent of the patient
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | keiichi Kubota |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
Address
880 kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2158
kubotak@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | keiichi Kubota |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
Address
880 kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2158
Homepage URL
kubotak@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan and South Korea through the Japan Biliary Association, the South Korea Biliary Association, and the South Korean Society of Hepato-Biliary-Pancreatic Surgery
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
| 2016 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
Registration factory Wanted
Management information
Registered date
| 2016 | Year | 06 | Month | 28 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026432
