UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020074 |
|---|---|
| Receipt number | R000023188 |
| Scientific Title | Efficacy of the shear wave elastography in the pancreas with liver cirrhosis patients |
| Date of disclosure of the study information | 2015/12/05 |
| Last modified on | 2018/06/11 12:38:21 |
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Basic information
Public title
Efficacy of the shear wave elastography in the pancreas with liver cirrhosis patients
Acronym
Stiffness of pancreas in liver cirrhosis
Scientific Title
Efficacy of the shear wave elastography in the pancreas with liver cirrhosis patients
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoichi Hiasa |
Organization
Ehime University Hospital
Division name
Gastroenterology and Metabology
Zip code
Address
Shitsukawa, Toon, Ehime, Japan
TEL
81-89-960-5308
hiasa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taira Kuroda |
Organization
Ehime University Hospital
Division name
Gastroenterology and Metabology
Zip code
Address
Shitsukawa, Toon, Ehime, Japan
TEL
81-89-960-5308
Homepage URL
taira@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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 | 10 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023188
