UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective evaluation of endoscopic ultrasonography in patients with early chronic pancreatitis, compared with MRI imaging
Title of the study (Brief title)	Retrospective evaluation of endoscopic ultrasonography in patients with early chronic pancreatitis, compared with MRI imaging
Region	Japan

Condition
Condition	Early chronic pancreatitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	in this study, we evaluate the objectivity of endoscopic ultrasonography in patients with early chronic pancreatitis, compared with MRI imaging.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	imagings of EUS and MRI
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients examined by EUS and MRI
Key exclusion criteria	refusal to participate
Target sample size	150

Research contact person
Name of lead principal investigator	Atsushi Irisawa
Organization	Fukushima medical university Aizu medical center
Division name	Department of Gastroenterology
Address	21-2 Maeda Tanisawa Kawahigashi Aizuwakamatsu City Fukushima Japan
TEL	0242-75-2100
Email	irisawa@fmu.ac.jp

Public contact
Name of contact person	Mariko Fujisawa
Organization	Fukushima medical university Aizu medical center
Division name	Department of Gastroenterology
Address	Department of Gastroenterology
TEL	0242-75-2100
Homepage URL
Email	mariko-f@fmu.ac.jp

Sponsor
Institute	Fukushima medical university Aizu medical center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Fukushima medical university Aizu medical center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 04 Month 13 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 07 Month 31 Day
Anticipated trial start date	2015 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Without intervention, be the observational study. A study period is from july, 2015 to November, 2015.

Management information
Registered date	2016 Year 04 Month 12 Day
Last modified on	2016 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025242