UMIN-CTR Clinical Trial

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
Email	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
Email	ninai@shinshu-u.ac.jp

Sponsor
Institute	Shinshu university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048276