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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022933
Receipt No. 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

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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
Email 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
Email kubotak@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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