UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of the shear wave elastography in the pancreas with liver cirrhosis patients
Title of the study (Brief title)	Stiffness of pancreas in liver cirrhosis
Region	Japan

Condition
Condition	liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether the pancreatic stiffness level measured by shear wave elastography is useful as diagnostic method of the pancreas congestion due to the portal hypertension.
Basic objectives2	Others
Basic objectives -Others	To evaluate whether the pancreas stiffness level can predict endocrine function abnormality in patients with liver cirrhosis.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	A correlation of the drainage time from pancreas and the stiffness of the pancreas
Key secondary outcomes	A correlation of the drainage time from pancreas and the hepatic venous pressure gradient (HVPG); and the endocrine function. A correlation of the stiffness (liver, spleen, pancreas) and the HVPG; and the endocrine function; and the parameter of portal hypertension (splenic volume, ascites, varices).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Shear wave elastography glucagon stimulation test oral glucose tolerance test
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	Patients with liver cirrhosis or chronic hepatitis who will be performed an examination of angiography.
Key exclusion criteria	Laboratory increases in pancreatic enzymes. Morphologic changes in pancreas. Past treatment history related to portal hypertension. Diabetes. Alcohol consumer. Administered beta-blockers. Clinical condition that could have caused portal hypertension. Poor pancreatic study with ultrasound.
Target sample size	100

Research contact person
Name of lead principal investigator	Yoichi Hiasa
Organization	Ehime University Hospital
Division name	Gastroenterology and Metabology
Address	Shitsukawa, Toon, Ehime, Japan
TEL	81-89-960-5308
Email	hiasa@m.ehime-u.ac.jp

Public contact
Name of contact person	Taira Kuroda
Organization	Ehime University Hospital
Division name	Gastroenterology and Metabology
Address	Shitsukawa, Toon, Ehime, Japan
TEL	81-89-960-5308
Homepage URL
Email	taira@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University Hospital
Institute
Department

Funding Source
Organization	Ehime University Hospital
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	愛媛大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry	2020 Year 09 Month 30 Day
Date trial data considered complete	2020 Year 09 Month 30 Day
Date analysis concluded	2020 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 04 Day
Last modified on	2018 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023188