UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010097 |
|---|---|
| Receipt number | 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 21:22:18 |
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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
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
atsushih@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011830
| 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 |
