Liver function change assessed by ALBI grade after selective transarterial chemoembolization for hepatocellular carcinoma: Ancillary analysis from the PRESIDENT study(JIVROSG-2001)

Liver function change assessed by ALBI grade after selective transarterial chemoembolization for hepatocellular carcinoma: Ancillary analysis from the PRESIDENT study(JIVROSG-2001) - PRESIDENT-ALBI study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043360

Enrollment

200

Registered

2021-03-01

Start date

2021-05-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To compare the deterioration of ALBI grade after 3 months of treatment with DEB-TACE and cTACE.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactYOSHIHISA KODAMA

Teine Keijinkai Hospital Department of Radiology

ykodama@mud.biglobe.ne.jp011-681-8111

Outcome results