UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025522 |
|---|---|
| Receipt number | R000029366 |
| Scientific Title | Gastrointestinal varix and refractory ascites registry |
| Date of disclosure of the study information | 2017/01/09 |
| Last modified on | 2022/01/08 17:37:29 |
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Basic information
Public title
Gastrointestinal varix and refractory ascites registry
Acronym
Varix and ascites registry
Scientific Title
Gastrointestinal varix and refractory ascites registry
Scientific Title:Acronym
Varix and ascites registry
Region
| Japan |
Condition
Condition
Gastrointestinal varix, refractory ascites
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify clinical epidemiology of gastrointestinal varix and refractory ascites in Japan
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short- and long-term outcome
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who has gastrointestinal varix and/or refractory ascites.
The registry requires a written informed consent from each patient.
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshida |
Organization
Nippon Medical School
Division name
GI and HBP Surgery
Zip code
113-8603
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-5814-6239
hiroshiy@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshida |
Organization
The Japan Society for Portal Hypertension
Division name
database committee
Zip code
100-0003
Address
Tokyo, Chiyoda-Ku, Hitotsubashi 1-1-1
TEL
03-6267-4550
Homepage URL
hiroshiy@nms.ac.jp
Sponsor or person
Institute
The Japan Society for Portal Hypertension
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for Portal Hypertension
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 Ethical Committee
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
Tel
03-5814-6239
hiroshiy@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および他施設 / Nippon Medical School and multi center
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 09 | 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
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2022 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029366
| Research Plan | |
|---|---|
| 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 |
