UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter study for isolated proximal IgG4-relaed sclerosing cholangitis: diagnosis and prognosis
Title of the study (Brief title)	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	kensuke kubota
Organization	Yokohama City University Hospital
Division name	Endoscopic devision
Address	3-9 Fukuura,Kanazawa, Yokohama,Japan
TEL	0457872800
Email	kubotak@yokohama

Public contact
Name of contact person	takuya takayanagi
Organization	Yokohama City University Hospital
Division name	Endoscopic devision
Address	3-9 Fukuura,Kanazawa, Yokohama,Japan
TEL	0457872800
Homepage URL
Email	t_takayanagi1987@yahoo.co.jp

Sponsor
Institute	Administration of health and welfare
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037656