UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010790 |
|---|---|
| Receipt number | R000012629 |
| Scientific Title | Evaluation for pancreatic blood flow and ability of endocrine in patients with portal hypertension |
| Date of disclosure of the study information | 2013/05/23 |
| Last modified on | 2013/05/23 17:48:55 |
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Basic information
Public title
Evaluation for pancreatic blood flow and ability of endocrine in patients with portal hypertension
Acronym
Pancreatic blood flow in patients with portal hypertension
Scientific Title
Evaluation for pancreatic blood flow and ability of endocrine in patients with portal hypertension
Scientific Title:Acronym
Pancreatic blood flow in patients with portal hypertension
Region
| Japan |
Condition
Condition
portal hypertension
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the pancreatic blood flow and the endocrine function in patients with portal hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diameter and wall-thickness of the pancreatic vein.
Degree of the insulin secretion in the islet of the pancreas.
The pancreatic hemodynamics by the ultrasonography.
Key secondary outcomes
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who underwent autopsy at the Ehime University Hospital from April, 2000 to October, 2012.
The patients with liver biopsy were diagnosed chronic hepatitis or cirrhosis histologically.
The control group.
Key exclusion criteria
Alcohol; more than 20g/day.
Heart failure.
During the pregnancy or while nursing.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teru Kumagi |
Organization
Ehime University Hospital
Division name
Gastroenterology and Metabology
Zip code
Address
Shizukawa, Toon, Ehime, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ehime University
Division name
Gastroenterology and Metabology
Zip code
Address
TEL
81-89-960-5308
Homepage URL
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The evaluation for pancreatic blood flow in the patients with portal hypertension.
Management information
Registered date
| 2013 | Year | 05 | Month | 23 | Day |
Last modified on
| 2013 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012629
