UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033030 |
|---|---|
| Receipt number | R000037656 |
| Scientific Title | Multicenter study for isolated proximal IgG4-relaed sclerosing cholangitis: diagnosis and prognosis |
| Date of disclosure of the study information | 2018/06/18 |
| Last modified on | 2019/01/08 15:04:46 |
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Basic information
Public title
Multicenter study for isolated proximal IgG4-relaed sclerosing cholangitis: diagnosis and prognosis
Acronym
isolated proximal IgG4-SC
Scientific Title
Multicenter study for isolated proximal IgG4-relaed sclerosing cholangitis: diagnosis and prognosis
Scientific Title:Acronym
isolated proximal IgG4-SC
Region
| Japan |
Condition
Condition
isolated proximal IgG4-SC
Classification by specialty
| Hepato-biliary-pancreatic medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The diagnostic rate for
isolated proximal IgG4-SC (IgG4-SC without autoimmune pancreatitis)
Basic objectives2
Others
Basic objectives -Others
Diagnosis and steroid effectiveness
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
diagnostic rate for isolated proximat IgG4-SC
Key secondary outcomes
1.cholangiography (ERC or MRCP)
2.endosonographic and/or intraductal urtrasonographic features of the bile duct
3. findings of extra-bile duct lesions
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Chalacteristic diffuse or segmental bile duct stricture with mucosal thickness
2.IgG4SC without autoimmune pancreatitis, nor atrophic pancreas
3.Presence of elavated serum IgG4 level over 135mg/dL
4.The presence with IgG4-related dacryoadenitis and/or IgG4-related retroperitoneal fibrosis
5.The histopathological findings;
1) marked Lymphoplasma cells infiltraion and fibrosis in the bile duct
2) IgG4-bearing plasmacells infiltration over 10cell/HPF
3) storiform fibrosis
4) obliterative phlebitis
6.steroid effectiveness
Definite diagnosis;
1+2+3+4
1+2+3+6 or 5
Key exclusion criteria
IgG4-SC with autoimmune pancreatitis
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kensuke kubota |
Organization
Yokohama City University Hospital
Division name
Endoscopic devision
Zip code
Address
3-9 Fukuura,Kanazawa, Yokohama,Japan
TEL
0457872800
kubotak@yokohama
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | takuya takayanagi |
Organization
Yokohama City University Hospital
Division name
Endoscopic devision
Zip code
Address
3-9 Fukuura,Kanazawa, Yokohama,Japan
TEL
0457872800
Homepage URL
t_takayanagi1987@yahoo.co.jp
Sponsor or person
Institute
Administration of health and welfare
Institute
Department
Personal name
Funding Source
Organization
Administration of health and welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
横浜市立大学附属病院及び国内先端施設
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 18 | 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
| 2018 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2018 | Year | 06 | Month | 17 | Day |
Last modified on
| 2019 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037656
| 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 |
