UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045140 |
|---|---|
| Receipt number | R000051569 |
| Scientific Title | Usefulness of BRTO for hepatic encephalopathy ; a multicenter retrospective observational study |
| Date of disclosure of the study information | 2021/08/15 |
| Last modified on | 2021/08/12 16:56:23 |
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Basic information
Public title
Usefulness of BRTO for hepatic encephalopathy ; a multicenter retrospective observational study
Acronym
The investigation for usefulness of BRTO for hepatic encephalopathy
Scientific Title
Usefulness of BRTO for hepatic encephalopathy ; a multicenter retrospective observational study
Scientific Title:Acronym
The investigation for usefulness of BRTO for hepatic encephalopathy
Region
| Japan |
Condition
Condition
Hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the usefulness of BRTO for hepatic encephalopathy at our hospital and related facilities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of time to onset of overt encephalopathy between shunt-closed group and shunt-patency group after BRTO
Key secondary outcomes
After BRTO, the factors affecting shunt patency were examined by comparing each factor in the shunt-closed group and the shunt-patency group
Compare survival time, liver function changes, and complication rates in the shunt-closed group and the shunt-patented group after BRTO
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 who underwent BRTO for hepatic encephalopathy from April 1, 2005 to October 1, 2020
Key exclusion criteria
Patients for whom the principal investigator and the research coordinator are deemed unsuitable for participation in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Hidaka |
Organization
Kitasato University Hospital
Division name
Gastroenterology
Zip code
252-0329
Address
1-15-1 Kitazato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
042-778-8111
hisashi7@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Uoshima |
Organization
Kitasato University Hospital
Division name
Gastroenterology
Zip code
252-0329
Address
1-15-1 Kitazato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
042-778-8111
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Kitasato University Hospital
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
Department of Gastroenterology, Kitasato University Hospital
Address
1-15-1 Kitazato, Minami-ku, Sagamihara City, Kanagawa Prefecture
Tel
042-778-8111
rinrib@med.kitasato-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 15 | 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
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate and determine whether or not BRTO were useful treatment for the patients with over HE, we investigated the influence of BRTO on the management of encephalopathy and the risk of the worsening portal hypertension.
According to the influence of the management of HE, we access the event free survival and over all survival. We also evaluated the change in the Lab after procedure.
According to evaluation for the risk of worsening portal hypertension, we accessed the occurrence of the complication related portal hypertension which was defined as the ascites, gastrointestinal varix and portal vein thrombosis.
Management information
Registered date
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051569
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
