UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043360 |
|---|---|
| Receipt number | R000048711 |
| Scientific Title | Liver function change assessed by ALBI grade after selective transarterial chemoembolization for hepatocellular carcinoma: Ancillary analysis from the PRESIDENT study(JIVROSG-2001) |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/02/20 08:45:16 |
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Basic information
Public title
Liver function change assessed by ALBI grade after selective transarterial chemoembolization for hepatocellular carcinoma: Ancillary analysis from the PRESIDENT study(JIVROSG-2001)
Acronym
PRESIDENT-ALBI study
Scientific Title
Liver function change assessed by ALBI grade after selective transarterial chemoembolization for hepatocellular carcinoma: Ancillary analysis from the PRESIDENT study(JIVROSG-2001)
Scientific Title:Acronym
PRESIDENT-ALBI study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of selective TACE on the deterioration of liver function due to differences in embolic agents.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the deterioration of ALBI grade after 3 months of treatment with DEB-TACE and cTACE.
Key secondary outcomes
To compare the deterioration of ALBI grade/mALBI grade/Child-Pugh score/ Child-Pugh class after 4 weeks/3 months of treatment with DEB-TACE and cTACE/ CR or non-CR.
To compare the difference of ALBI score/ Child-Pugh score after 4 weeks/ 3 month of treatment with DEB-TACE and cTACE/ CR or non-CR.
To perform an exploratory analysis of risk factors associated with the deterioration of ALBI score after 4 weeks/ 3 month of treatment.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically or clinically diagnosed hepatocellular carcinoma
2. No indication for surgical resection, liver transplantation, or local ablation therapy
3. Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection and possible to perform selective TACE
4. No previous treatment for HCC nodules in which TACE is planned
5. Measurable HCC nodules in which TACE is planned
6. Maximum HCC nodule of 5cm or less in which TACE is planned
7. ECOG Performance Status 0-1
8. Child-Pugh A or B
9. Adequate organ function
a. T-Bil<=3.0 mg/dL
b. AST/ALT within 5 times of upper normal limit or 250 IU/L
10. Age of 20 years or over
11. Written informed consent
Key exclusion criteria
1. Tumor thrombosis in portal vein
2. Extrahepatic metastasis
3. Ruptured HCC nodules in which TACE is planned
4. Extrahepatic feeding arteries for HCC nodules in which TACE is planned
5. Prior surgical reconstruction or endoscopic treatment of the biliary tract
6. Clinically significant refractory ascites or pleural effusion
7. Severe arterio-portal or arterio-venous shunts in the liver
8. Allergy to contrast medium that precludes angiography
9. Previously registered patients in this study
10. Severe, active co-morbidity
11. Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing or able to use medically acceptable forms of contraception
12. Not eligible because of safety issues judged by investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | YOSHIHISA |
| Middle name | |
| Last name | KODAMA |
Organization
Teine Keijinkai Hospital
Division name
Department of Radiology
Zip code
006-8555
Address
1-12-1-40 Maeda Teineku Sapporo JAPAN 006-8555
TEL
011-681-8111
ykodama@mud.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | YOSHIHISA |
| Middle name | |
| Last name | KODAMA |
Organization
Teine Keijinkai Hospital
Division name
Department of Radiology
Zip code
006-8555
Address
1-12-1-40 Maeda Teineku Sapporo JAPAN 006-8555
TEL
011-681-8111
Homepage URL
ykodama@mud.biglobe.ne.jp
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
Funding Source
Organization
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teine Keijinkai Hospital
Address
1-12-1-40 Maeda Teineku Sapporo JAPAN 006-8555
Tel
011-681-8111
tkh-rinriml@keijinkai.or.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
国立がん研究センター東病院 (千葉県)
愛知県がんセンター中央病院 (愛知県)
奈良県立医科大学 (奈良県)
国立がん研究センター中央病院 (東京都)
手稲渓仁会病院 放射線診断科 (北海道)
静岡県立静岡がんセンター (静岡県)
市立奈良病院 (奈良県)
新潟大学地域医療教育センター魚沼基幹病院 (新潟県)
信州大学医学部附属病院 (長野県)
新潟県立がんセンター新潟病院 (新潟県)
龍ケ崎済生会病院 (茨城県)
新潟大学病院医歯学総合研究科 (新潟県)
琉球大学医学部附属病院 (沖縄県)
近畿大学付属病院 (大阪府)
大阪府立急性期・総合医療センター (大阪府)
群馬大学医学部附属病院 (群馬県)
北海道大学 (北海道)
岩手医科大学 (岩手県)
京都府立医科大学 (京都府)
京都府立医科大学附属北部医療センター (京都府)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | 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
197
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective ancillary analysis study from JIVROSG-1302:PRESIDENT study (UMIN000021250).
Inclusion criterion: Patients enrolled in the JIVROSG-1302:PRESIDENT study.
Exclusion criteria:
1. Patients in which Split TACE was performed.
2. Patients without serum albumin levels drawn after 4 weeks and 3 months of treatment.
3. Patients without serum total bilirubin level drawn after 4 weeks and 3 months of treatment.
Information such as age, gender, blood collection results, imaging, medical history, treatment course, etc. will be collected from the JIVROSG-1302: PRESIDENT study data and collected from participating centers in additional CRFs.
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048711
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