UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025522
Receipt No. R000029366
Scientific Title Gastrointestinal varix and refractory ascites registry
Date of disclosure of the study information 2017/01/09
Last modified on 2019/03/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Yoshida
Organization Nippon Medical School
Division name GI and HBP Surgery
Zip code
Address Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL 03-5814-6239
Email hiroshiy@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Yoshida
Organization The Japan Society for Portal Hypertension
Division name database committee
Zip code
Address Tokyo, Chiyoda-Ku, Hitotsubashi 1-1-1
TEL 03-6267-4550
Homepage URL
Email hiroshiy@nms.ac.jp

Sponsor
Institute The Japan Society for Portal Hypertension
Institute
Department

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
Address
Tel
Email

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
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.