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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010790
Receipt No. 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

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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
Email

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
Email

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012629

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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