UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052853 |
|---|---|
| Receipt number | R000060315 |
| Scientific Title | The impact of portal vein major circulation short-circuit embolization on the clinical course of the disease. |
| Date of disclosure of the study information | 2023/11/21 |
| Last modified on | 2024/12/22 10:12:52 |
* 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
The impact of portal vein major circulation short-circuit embolization on the clinical course of the disease.
Acronym
The impact of portal vein major circulation short-circuit embolization on the clinical course of the disease.
Scientific Title
The impact of portal vein major circulation short-circuit embolization on the clinical course of the disease.
Scientific Title:Acronym
The impact of portal vein major circulation short-circuit embolization on the clinical course of the disease.
Region
| Japan |
Condition
Condition
diffuse liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
BRTO, which embolizes the portal vein major circulation short circuit, has been reported to improve liver function, but it can lead to refractory ascites and other problems, so it has not been determined in which patients it should be performed. This may be due in part to the fact that few comparisons of prognosis have been made between patients treated with and without BRTO. Therefore, we will examine the prognosis and the incidence of noncompensated events with and without BRTO retrospectively among patients with a well-developed portal hypertension, in order to identify patients who truly need BRTO.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of overall survival within the study period with and without BRTO
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
Patients who meet all of the following conditions are eligible
(1) Patients with diffuse liver disease
Key exclusion criteria
Patients who meet any of the following conditions are not eligible
1) Patients who are deemed by the investigator or subinvestigator to be unsuitable for the safe conduct of this study.
2) Patients who have expressed their refusal to participate in this study through a disclosure document.
3) Any other cases in which the safety of the patient may be compromised in the conduct of this study or in which it is deemed difficult to comply with the study protocol.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2648677
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
TEL
43222717
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kondo |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
TEL
43222717
Homepage URL
takakon@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Chiba University Hospital
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
Tel
43222717
fujimoto.kentarou@chiba-u.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
| 2023 | Year | 11 | Month | 21 | 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
| 2023 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical and hematological data of patients with diffuse liver disease will be reviewed retrospectively and compared with and without BRTO to verify prognosis and the incidence of noncompensated events, and to derive cases that are good indications for BRTO.
Management information
Registered date
| 2023 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060315
