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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010097
Receipt No. R000011830
Scientific Title Diagnosis of autoimmune pancreatitis by EUS-FNA using a 22-gauge needle: a prospective multicenter study
Date of disclosure of the study information 2013/02/22
Last modified on 2017/02/26

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Basic information
Public title Diagnosis of autoimmune pancreatitis by EUS-FNA using a 22-gauge needle: a prospective multicenter study
Acronym Diagnosis of AIP by EUS-FNA using a 22-gauge needle
Scientific Title Diagnosis of autoimmune pancreatitis by EUS-FNA using a 22-gauge needle: a prospective multicenter study
Scientific Title:Acronym 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
1st name
Middle name
Last name Tooru Shimosegawa
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
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
1st name
Middle name
Last name Atsushi Kanno
Organization Tohoku University Hospital
Division name Department of Gastroenterology
Zip code
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)

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
2013 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 11 Month 26 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000011830

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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