UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk Factors and Therapies for Gastric Variceal Bleeding in Japan:prospective study
Title of the study (Brief title)	RIFTGV-J:prospective study
Region	Japan

Condition
Condition	Patients with ruptured gastric fundal varices
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and complications of initial and subsequent treatments for bleeding from gastric fundal varices
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cumulative rebleeding rates in patients with ruptured gastric fundal varices
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients with ruptured gastric fundal varices diagnosed via endoscopy in the National Hospital Organization Hospitals 2.Gastric fundal varices with the presence of gastro-renal shunts defined via computed tomography 3.For patients with HCC the Milan criteria were applied (a solitary nodule < or = 5 cm; or two or three nodules < or = 3 cm without vascular invasion or extrahepatic metastasis), and patients were to undergo potentially curative treatments
Key exclusion criteria	1.Patients with advanced HCC who were unable to undergo curative treatment 2. Patients with a solitary HCC (more than 5cm in a diameter of the tumor) who received surgical treatment 3.Recurrent HCC 4.Portal vein thrombosis 5.Other malignancies without curative treatments 6.T.Bil > or =4mg/dl 7.Parmanent organ failure except for liver failure 8.Patients failed to hemostasis, or died within 24 hours from onset of bleeding 9. Patients received prior treatments of gastric varices (e.g., TIPS, surgery, PSE or splenectomy) 10.Patients whom judged to be inadequate by the doctor
Target sample size	160

Research contact person
Name of lead principal investigator	Yasuhiro Makino
Organization	National Hospital Organization Iwakuni Clinical Center
Division name	Internal Medicine
Address	2-5-1 Kuroiso-cho, Iwakuni, Yamaguchi , Japan
TEL
Email

Public contact
Name of contact person	Kazuya Kimura
Organization	National Hospital Organization Iwakuni Clinical Center
Division name	Department of Clinical Research
Address
TEL
Homepage URL	http://www.csecr.jp/
Email

Sponsor
Institute	National Hospital Organization Head quarter
Institute
Department

Funding Source
Organization	National Hospital Organization Head quarter
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2007 Year 09 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2007 Year 07 Month 01 Day
Anticipated trial start date	2007 Year 07 Month 01 Day
Last follow-up date	2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://poppy.ac/nho/index.html
Publication of results	Unpublished
URL releasing results
Results
Other related information	Informations of this study will be accessed via web of NHO EBM Project

Management information
Registered date	2007 Year 07 Month 30 Day
Last modified on	2019 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000839