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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041352
Receipt No. R000047211
Scientific Title Usefulness of Endoscopic Ultrasound-guided Fine-needle Biopsy for the Diagnosis of Type 1 Autoimmune Pancreatitis Using a 19G Franseen needle
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/07

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Basic information
Public title Usefulness of Endoscopic Ultrasound-guided Fine-needle Biopsy for the Diagnosis of Type 1 Autoimmune Pancreatitis Using a 19G Franseen needle
Acronym AIP 19G Franseen Needle study
Scientific Title Usefulness of Endoscopic Ultrasound-guided Fine-needle Biopsy for the Diagnosis of Type 1 Autoimmune Pancreatitis Using a 19G Franseen needle
Scientific Title:Acronym AIP 19G Franseen Needle study
Region
Japan

Condition
Condition Type 1 autoimmune pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of EUS-FNB using a 19G Franseen needle for the diagnosis of type 1 autoimmune pancreatitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Histological diagnostic accuracy of EUS-FNB using a 19G Franseen needle for type 1 autoimmune pancreatitis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Using a 19G Franseen needle.
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 Patients who met the imaging and clinical findings based on the international consensus diagnostic criteria and require histological evaluation by EUS-FNB.
Key exclusion criteria Not possible to suspend antithrombotic drugs
poorly controlled infection
serious drug allergy
current pregnancy or lactation, possible pregnancy, or possible intent to become pregnant
severe mental disorders
judgment of ineligibility by the principal investigator or subinvestigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Ishikawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 4668550
Address Tsuruma-cho, Showa-ku, Nagoya
TEL 0527442602
Email ishitaku@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Ishikawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 4668550
Address Tsuruma-cho, Showa-ku, Nagoya
TEL 0527442602
Homepage URL
Email ishitaku@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee of Nagoya University Hospital
Address 65, Tsuruma-cho, Showa-ku, Nagoya, 4668550
Tel 0527442479
Email iga-shinsa@adm.nagoya-u.ac.jp

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
2020 Year 09 Month 01 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
2020 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 07 Day
Last modified on
2020 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047211

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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