UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis of autoimmune pancreatitis by EUS-FNA using a 22-gauge needle: a prospective multicenter study
Title of the study (Brief title)	Diagnosis of AIP by EUS-FNA using a 22-gauge needle
Region	Japan

Condition
Condition	Autoimmune pancreatitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of EUS-FNA using a 22-G needle for the histopathological diagnosis of AIP.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	To validate the histological specimen obtained by EUS-FNA using 1 22G needle for the diagnosis of AIP based on the ICDC.
Key secondary outcomes	Feasible study of the EUS-FNA using a 22G needle for the diagnosis of atypical cases with AIP (type 2 or AIP-NOS).

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Cases suspected of AIP 2)Cases with written oral informed consent after the oral explanation 3)Cases with performance status (PS) 0-1
Key exclusion criteria	1)Cases with hemorrhagic tendency 2)Cases with difficulty in the insertion of a endoscope 3)Cases that endoscopist cannot detect the swelling of the pancreas by EUS due to past history of anastomosis of the gastrointestinal tract such as gastrectomy 4)Cases with severe complications 5)Cases that doctors regard as inappropriate ones for the enrollmentfor some reasons
Target sample size	50

Research contact person
Name of lead principal investigator	Tooru Shimosegawa
Organization	Tohoku University Graduate School of Medicine
Division name	Division of Gastroenterology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL	022-717-7171
Email	tshimosegawa@int3.med.tohoku.ac.jp

Public contact
Name of contact person	Atsushi Kanno
Organization	Tohoku University Hospital
Division name	Department of Gastroenterology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL	022-717-7171
Homepage URL
Email	atsushih@med.tohoku.ac.jp

Sponsor
Institute	Division of Gastroenterology, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Research Committee on Intractable Pancreatic Diseases, supported by the Ministry of Health, Labour, and Welfare of Japan.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 26 Day
Anticipated trial start date	2013 Year 02 Month 22 Day
Last follow-up date
Date of closure to data entry	2014 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	1)To validate the histological specimen obtained by EUS-FNA using 1 22G needle for the diagnosis of AIP based on the ICDC. 2)Feasible study of the EUS-FNA using a 22G needle for the diagnosis of atypical cases with AIP (type 2 or AIP-NOS).

Management information
Registered date	2013 Year 02 Month 22 Day
Last modified on	2017 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011830