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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042396
Receipt No. R000048358
Scientific Title Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial
Date of disclosure of the study information 2020/11/10
Last modified on 2020/11/09

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Basic information
Public title Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial.
Acronym Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial
Scientific Title Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial
Scientific Title:Acronym Efficacy of wet suction teqnique in endoscopic ultrasongraphy guided fine needle biopsy for the diagnosis of autoimmune pancreatitis using 22 gauge franseen needle: a prospective randomized-control trial
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether using wet suction teqnique can improve the histological diagnosability of EUS-FNB with franseen needle or not in AIP patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The cases who show Level 1 or Level 2 histlogical findings that were difinited in 2010 International Consensus Diagnostic criteria of AIP.
Key secondary outcomes 1. The cases who show Level 1 histlogical findings that were difinited in 2010 International Consensus Diagnostic criteria of AIP.
2. The cases who show each four histlogical findings that were difinited in 2010 International Consensus Diagnostic criteria of AIP. These findings are
(1) Lymphoplasmacytic infiltrate without granulocytic infiltration
(2) Obliterative phlebitis
(3) Storiform fibrosis
(4) Abundant (> 10 cells/HPF) IgG4 positive cells
3. Adverse events
4. The cases who are obtained histological specimen
5. Number of punctures
6. The cases whose specimen is sufficient for immunostain

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Food Maneuver
Interventions/Control_1 EUS-FNB with wet suction technique
Interventions/Control_2 Conventional EUS-FNB without wet suction technique
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. Elevated serum IgG4 (no less thatn 135 mg/dl
2. The cases who show pancreatic swelling by echo, CT, MRI, etc.... and who are thought to be AIP.
Key exclusion criteria 1. Elevated serum IgG4 are not observed.
2. The cases who have already been administered steroid and whose IgG4, disease have been already improved.
3. The cases who can't be performed EUS-FNA (difficult to insert scope, bleeding tendency).
4. The cases who can't stop antithrombotic according to the gastroinert endoscopy guideline.
d. The cases who were not sufficiently sedated.
e. The cases who disagree with this RCT.
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Hiromasa
Middle name
Last name Ohira
Organization Fukushima Medical University, School of Medicine
Division name Gastroenterology
Zip code 960-1295
Address 1 Hikarigaoka, Fukushima City
TEL +81-24-547-1111
Email h-ohira@fmu.ac.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Sugimoto
Organization Fukushima Medical University, School of Medicine
Division name Department of Gastroenterology
Zip code 960-1295
Address 1 Hikarigaoka
TEL +81-24-547-1111
Homepage URL
Email kita335@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fukushima Medical University
Address 1 Hikarigaoka
Tel +81-24-547-1825
Email rs@fmu.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 11 Month 10 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 10 Month 22 Day
Date of IRB
2020 Year 10 Month 22 Day
Anticipated trial start date
2020 Year 11 Month 10 Day
Last follow-up date
2025 Year 11 Month 10 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 11 Month 09 Day
Last modified on
2020 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048358

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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