UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of EUS-FNA with wet suction technique (WEST) for auto immune pancreatitis
Acronym	The efficacy of EUS-FNA with WEST for AIP
Scientific Title	The efficacy of EUS-FNA with wet suction technique (WEST) for auto immune pancreatitis
Scientific Title:Acronym	The efficacy of EUS-FNA with WEST for AIP
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of EUS-FNA with wet suqtion technique (WEST) for AIP type 1
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The diagnosability of 4 items described for LPSP in Internal consensus diagnostic criteria
Key secondary outcomes	1.The number of IgG4 positive plasma cells in a high power field 2.Complications 3.The number of needle passes for sampling 4.The number needle passes 5.Whether can take sufficient quantitiy for immunostaining or not

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	Maneuver
Interventions/Control_1	Needles of EUS-FNA were flushed with saline solution.
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	AIP patients older than 20 years with elevated serum IgG4
Key exclusion criteria	1. AIP patients without elevated serum IgG4. 2. AIP patients who have already been performed steroid therapy. 3. EUS-FNA is impossible (cannot insert the scope, profound bleeding risk, etc) 4. Patients who cannot stop antithorombotic drugs for EUS-FNA. 5. Patients who don't agree with informed consent.
Target sample size	10

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	Department of Gastroenterology
Zip code	960-1295
Address	1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL	024-547-1202
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, Fukushima City, Fukushima Prefecture
TEL	024-547-1202
Homepage URL
Email	kita335@fmu.ac.jp

Sponsor
Institute	Department of Gastroenterology, Fukushima Medical University, School of Medicine
Institute
Department

Funding Source
Organization	Gastroenterology, Fukushima Medical University, School of Medicine
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	Hikarigaoka 1, Fukushima City, Japan
Tel	024-547-1825
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	2015 Year 11 Month 12 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	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 12 Day
Date of IRB	2015 Year 10 Month 22 Day
Anticipated trial start date	2015 Year 11 Month 12 Day
Last follow-up date	2030 Year 01 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	2015 Year 11 Month 12 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022827