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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044464
Receipt No. R000050793
Scientific Title A study on the usefulness of sound velocity correction mode in ultrasonography endoscopy for chronic pancreatitis
Date of disclosure of the study information 2021/06/10
Last modified on 2021/06/07

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Basic information
Public title A study on the usefulness of sound velocity correction mode in ultrasonography endoscopy for chronic pancreatitis
Acronym Comparison of ultrasound velocity in different stages of chronic pancreatitis
Scientific Title A study on the usefulness of sound velocity correction mode in ultrasonography endoscopy for chronic pancreatitis
Scientific Title:Acronym Comparison of ultrasound velocity in different stages of chronic pancreatitis
Region
Japan

Condition
Condition Chronic pancreatitis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether differences in ultrasound velocity occur with the progression of chronic pancreatitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the relevance of the optimal ultrasound speed (USS)for each degree of chronic pancreatitis (CP)according the Japanese diagnostic criterion for CP in 2019 (JDCCP2019) and to investigate whether the analysis of USS contributes to the diagnosis of CP.
Key secondary outcomes calculation of cutoff value for early-stage CP on JDCCP2019.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 SU-1 ultrasound processor (FUJIFILM Medical Co., Ltd, Tokyo, Japan) with linear/radial arrayed EUS scope (EG580UR, EG-580UT; FUJIFILM Medical Co., Ltd, Tokyo, Japan)
Patients who were deemed to require pancreatic evaluation were included in the study; the time period of inclusion was set from December 2018 to September 2021.
Interventions/Control_2 SU-1 ultrasound processor (FUJIFILM Medical Co., Ltd, Tokyo, Japan) with linear/radial arrayed EUS scope (EG580UR, EG-580UT; FUJIFILM Medical Co., Ltd, Tokyo, Japan)
Patients who were deemed to require pancreatic evaluation were included in the study; the time period of inclusion was set from December 2018 to September 2021.
Interventions/Control_3 SU-1 ultrasound processor (FUJIFILM Medical Co., Ltd, Tokyo, Japan) with linear/radial arrayed EUS scope (EG580UR, EG-580UT; FUJIFILM Medical Co., Ltd, Tokyo, Japan)
Patients who were deemed to require pancreatic evaluation were included in the study; the time period of inclusion was set from December 2018 to September 2021.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients requiring EUS for pancreatic scrutiny.
Patients who have been fully informed about the research and have given written consent of their own free will with full understanding.
Key exclusion criteria Patients deemed inappropriate by the principal investigator or sub-investigator
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Irisawa
Organization Dokkyo Medical University School of medicine
Division name Department of Gastroenterology
Zip code 321-0293
Address Tochigi, Japan
TEL 0282-86-1111
Email irisawa@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Takahito
Middle name
Last name Minaguchi
Organization Dokkyo Medical University School of medicine
Division name Department of Gastroenterology
Zip code 321-0293
Address Tochigi, Japan
TEL 0282-86-1111
Homepage URL
Email takahito@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University School of medicine
Institute
Department

Funding Source
Organization Dokkyo 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 Dokkyo Medical University School of medicine
Address Tochigi,Japan
Tel 0282861111
Email takahito@dokkyomed.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 獨協医科大学病院(栃木県)

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
2020 Year 07 Month 20 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2021 Year 09 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 07 Day
Last modified on
2021 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050793

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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