UMIN-CTR Clinical Trial

Basic information
Public title	A prospective validation study of diagnostic yield of EUS-FNB estimated by stereomicroscopic visible white core length
Acronym	A prospective validation study of diagnostic yield of EUS-FNB estimated by stereomicroscopic visible white core length
Scientific Title	A prospective validation study of diagnostic yield of EUS-FNB estimated by stereomicroscopic visible white core length
Scientific Title:Acronym	A prospective validation study of diagnostic yield of EUS-FNB estimated by stereomicroscopic visible white core length
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of cut-off value of stereomicroscopic visible white core length required for pathological diagnosis of pancreatic cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sensitivity of pathological diagnosis using cut-off value
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Endoscopic ultrasound-guided biopsy using a 22-gauge biopsy needle (If there is no stereomicroscopic visible white core exceeding 11mm, perform additional puncture up to 5 times.)
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. providing written informed consent, and age =or >20 2. patients with pancreatic cancer suspected 3. unresectable or borderline resectable
Key exclusion criteria	1. patients with mental disorder 2. patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Kosuke Middle name Last name Okuwaki
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL	042-778-8111
Email	kokuwaki@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Masafumi Middle name Last name Watanabe
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL	042-778-8111
Homepage URL
Email	m.wata@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Kitasato 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	Kitasato University school of medicine, Institutional Review Board
Address	1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
Tel	042-778-8111
Email	rinrib@med.kitasato-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	Kitasto University Hospital(Kanagawa)，Isehara Kyodo Hospital(Kanagawa)，JCHO Sagamino Hospital(Kanagawa)

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 01 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	70
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	Main results already published
Date of protocol fixation	2019 Year 12 Month 17 Day
Date of IRB	2020 Year 02 Month 12 Day
Anticipated trial start date	2020 Year 02 Month 15 Day
Last follow-up date	2021 Year 12 Month 21 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 01 Month 16 Day
Last modified on	2021 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044515