UMIN-CTR Clinical Trial

Basic information
Public title	Epidemiological research of portopulmonary hypertension in patients with liver cirrhosis
Acronym	Epidemiological research of portopulmonary hypertension in patients with liver cirrhosis
Scientific Title	Epidemiological research of portopulmonary hypertension in patients with liver cirrhosis
Scientific Title:Acronym	Epidemiological research of portopulmonary hypertension in patients with 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 investigate the incidence of portopulmonary hypertension with liver cirrhosis, screening methods and diagnostic capabilities to diagnose portal pulmonary hypertension, the treatment, and the prognosis of patients with pulmonary hypertension with liver cirrhosis in Japan.
Basic objectives2	Others
Basic objectives -Others	Diagnostic method and accuracy to diagnose portopulmonary hypertension in patients with liver cirrhosis
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Diagnostic method and accuracy to diagnose portopulmonary hypertension in patients with liver cirrhosis
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed as liver cirrhosis based on the results of imaging modality (abdominal CT or ultrasonography) or proven by liver biopsy.
Key exclusion criteria	1. Patients with uncontrollable hepatocellular carcinoma, 2. Patients with chronic respiratory disease, 3. Patients with left ventricular heart disease, 4. Patients with chronic pulmonary embolism, 5. Patients with blood disease, 6. Patients with sarcoidosis 7. Patients with thyroid disease, 8. Patients with connective tissue disease, 9. Patients with Human Immunodeficiency Virus infection, 10. Patients with congenital heart disease
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Atsukawa
Organization	Nippon Medical School
Division name	Division of Gastroenterology and Hepatology
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan.
TEL	03-3822-2131
Email	momogachi@yahoo.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Atsukawa
Organization	Nippon Medical School
Division name	Division of Gastroenterology and Hepatology
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan.
TEL	03-3822-2131
Homepage URL	http://ctr-nms.com/disclosure/
Email	momogachi@yahoo.co.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	None
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	Nippon Medical School Hospital Ethics Committee
Address	1-1-5,Sendagi,Bunkyo-ku,Tokyo,Japan.
Tel	03-3822-2131
Email	nms_fuzokurinri@nms.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

日本医科大学付属病院(東京都)、日本医科大学千葉北総病院（千葉県）、日本医科大学武蔵小杉病院（神奈川県）、大垣市民病院（岐阜県）、国立病院機構九州医療センター（福岡県）、香川県立中央病院（香川県）、香川大学医学部付属病院（香川県）聖マリアンナ医科大学（神奈川県）、おおたかの森病院（千葉県）、新松戸中央総合病院（千葉県）、東京慈恵会医科大学（東京都）、東京慈恵会医科大学附属病院（東京都）、東京慈恵会医科大学附属柏病院（千葉県）、キッコーマン総合病院（千葉県）、東京医科大学茨城医療センター（茨城県）、名古屋市立大学病院（愛知県）、東京都立墨東病院　（東京都）、高松赤十字病院（香川県）、北里大学　（神奈川県）、大阪医科大学　（大阪府）、博慈会記念総合病院（東京都）、愛媛県立中央病院　（愛媛県）、横浜市立大学附属市民総合医療センター（神奈川県）、常磐病院（福島県）、岡山済生会総合病院（岡山県）、増子記念病院（愛知県）、順天堂大学医学部付属練馬病院（東京都）、藤田医科大学ばんたね病院（愛知県）、石巻赤十字病院（宮城県）、山口大学医学部付属病院（山口県）、大阪府済生会吹田病院（大阪府）、済生会新潟病院（新潟県）、手稲渓仁会病院（北海道）、三豊総合病院（香川県）、屋島総合病院（香川県）、浜松医科大学医学部付属病院（静岡県）、三重大学医学部付属病院（三重県） Nippon Medical School(Tokyo), Nippon Medical School Chiba Hokusoh Hospital(Chiba), Nippon Medical School Musashikosugi Hospital(Kanagawa), Ogaki Municipal Hospital(Gifu), National Hospital Organization Kyushu Medical Center(Fukuoka), Kagawa Prefectural Central Hospital(Kagawa), Kagawa University Hospital(Kagawa), St. Marianna University School of Medicine(Kanagawa), Otakanomori Hospital(Chiba), Shinmatsudo Central General Hospital(Chiba), The Jikei University School of Medicine(Tokyo), The Jikei University School of Medicine Kashiwa Hospital(Chiba), Kikkoman General Hospital(Chiba), Tokyo Medical University Ibaraki Medical Center(Ibaraki), Nagoya City University(Aichi), Tokyo Metropolitan Bokutoh Hospital(Tokyo), Takamatsu Red Cross Hospital(Kagawa), Kitasato University School of Medicine(Kanagawa), Osaka Medical College(Osaka), Hakujikai Memorial Hospital(Tokyo), Ehime Prefectural Central Hospital(Ehime), Yokohama City University Graduate School of Medicine(Kanagawa), Jyoban Hospital(Fukushima), Okayama Saiseikai General Hospital(Okayama), Masuko Memorial Hospital(Aichi), Juntendo Nerima University Hospital(Tokyo), Fujita Health University School of Medicine Bantane Hospital(Aichi), Japanese Red Cross Ishinomaki Hospital(Miyagi), Yamaguchi Unicersity Hospital(Yamaguchi), Saiseikai Suita Hospital(Osaka), Saiseikai Niigata Hospital(Niigata), Teine Keijinnkai Hospital(Hokkaido), Mitoyo General Hospital(Kagawa), Yashima General Hospital(Kagawa), Hamamatsu University School of Medicine(Shizuoka), Mie University School of Medicine(Mie)

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 18 Day

Related information
URL releasing protocol	http://ctr-nms.com/disclosure/
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 22 Day
Date of IRB	2020 Year 04 Month 22 Day
Anticipated trial start date	2020 Year 05 Month 18 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry	2025 Year 03 Month 31 Day
Date trial data considered complete	2025 Year 03 Month 31 Day
Date analysis concluded

Other

Other related information

Pick up the cases with electronic medical record, register the cases that meet the eligibility criteria, and register the patient background characteristics, treatment history of liver cirrhosis, transition of blood biochemical test results, and collect clinical data such as diagnostic methods to diagnose portopulmonary hypertension (chest radiography, echocardiography, electrocardiogram, hepatic vein and pulmonary artery catheters, etc.).

Management information
Registered date	2020 Year 05 Month 18 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046134