UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000784 |
|---|---|
| Receipt number | R000000839 |
| Scientific Title | Risk Factors and Therapies for Gastric Variceal Bleeding in Japan:prospective study |
| Date of disclosure of the study information | 2007/09/01 |
| Last modified on | 2019/02/06 13:33:16 |
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Basic information
Public title
Risk Factors and Therapies for Gastric Variceal Bleeding in Japan:prospective study
Acronym
RIFTGV-J:prospective study
Scientific Title
Risk Factors and Therapies for Gastric Variceal Bleeding in Japan:prospective study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Makino |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Internal Medicine
Zip code
Address
2-5-1 Kuroiso-cho, Iwakuni, Yamaguchi , Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Kimura |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Department of Clinical Research
Zip code
Address
TEL
Homepage URL
http://www.csecr.jp/
Sponsor or person
Institute
National Hospital Organization Head quarter
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
http://poppy.ac/nho/index.html
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
Terminated
Date of protocol fixation
| 2007 | Year | 07 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000839
