UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042287 |
|---|---|
| Receipt number | R000048276 |
| Scientific Title | Factual investigation of Portoplumonary hypertension in chronic liver disease |
| Date of disclosure of the study information | 2020/10/29 |
| Last modified on | 2021/02/24 19:48:46 |
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Basic information
Public title
Factual investigation of Portoplumonary hypertension in chronic liver disease
Acronym
Factual investigation of Portoplumonary hypertension in chronic liver disease
Scientific Title
Factual investigation of Portoplumonary hypertension in chronic liver disease
Scientific Title:Acronym
Factual investigation of Portoplumonary hypertension in chronic liver disease
Region
| Japan |
Condition
Condition
Chronic liver disease, Portoplumonary hypertension
Classification by specialty
| Hepato-biliary-pancreatic medicine | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical course of portal hypertension and the clinical course of diagnosed portal hypertension in patients with chronic liver disease.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the prevalence of PoPH in Japanese patients with chronic liver disease
Key secondary outcomes
the etiology of PoPH in Japanese patients with chronic liver disease
the overall 5-year survival rate
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
(1) Patients over 20 years of age who have been diagnosed with chronic liver disease in our hospital and present with clinical symptoms (e.g., chest pain, dyspnea, syncope, blood sputum, etc.) that are suspicious of PoPH.
(2) Patients diagnosed with portal hypertension who can be followed up in our hospital.
Key exclusion criteria
(1)Cases for which follow-up was not possible at our hospital
(2) Any other cases that the researcher deems inappropriate.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | Wakabayashi |
Organization
Shinshu university
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
390-08621
Address
3-1-1, Asahi, Matsumoto, Japan
TEL
0263-37-2634
ninai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | Wakabayashi |
Organization
Shinshu university
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
390-08621
Address
3-1-1, Asahi, Matsumoto, Japan
TEL
0263-37-2634
Homepage URL
ninai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Shinshu University Faculty of Medicine, Department of Gastroenterology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Ethics Committee
Address
3-1-1, Asahi, Matsumoto, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.ac.jp
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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 29 | 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
| 2020 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048276
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
