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Pathological evaluation of tumor necrosis in balloon-occluded versus conventional transcatheter arterial chemoembolization in patients with hepatocellular carcinoma: a randomized controlled trial

Pathological evaluation of tumor necrosis in balloon-occluded versus conventional transcatheter arterial chemoembolization in patients with hepatocellular carcinoma: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009977
Enrollment
100
Registered
2024-11-29
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-05-07

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

Conditions

None listed

Interventions

Procedure/Surgery : TACE involves performing hepatic artery angiography according to our hospital's standard treatment, inserting a microcatheter or microballoon catheter into the tumor blood vessel,

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients over 19 years of age 2. Patient signing consent form 3. Patients diagnosed with hepatocellular carcinoma by AASLD and at least one of the following methods i. Magnetic resonance imaging (MRI) with early enhancement and delayed enhancement of at least one solid liver lesion >1 cm ii. Contrast-enhanced CT with early enhancement and delayed enhancement of at least one solid liver lesion >1 cm iii. Histological confirmation is required for lesions with non-specific characteristics. 4. Patients who have not previously received any other treatment for HCC and for whom TACE and hepatectomy are the first treatments for HCC 5. Patients must be eligible for surgical hepatectomy or liver transplantation at the time of study enrollment. 6. It must be Child-Pugh A or B hepatocellular carcinoma, and must meet the following criteria. i. Tumor lesion size ranges from 1 cm to 10 cm ii. Tumor count 1-10 7. Patients who can be followed up until the end of the study and have a life expectancy of more than 6 months

Exclusion criteria

Exclusion criteria: 1. Patients under 19 years of age 2. Patients with chronic kidney disease (CKD) grade 4 or 5 3. Patients who received other treatments such as radiofrequency therapy, chemotherapy, sorafenib, or radiotherapy after being diagnosed with hepatocellular carcinoma 4. Pregnant women, lactating women, and women not using effective contraception. 5. If hepatocellular carcinoma has invaded major blood vessels of the liver or has metastasis outside the liver 6. Performance status ECOG > 1 7. Child-Pugh Grade C 8. Active gastrointestinal bleeding 9. Evidence of irreversible bleeding constitution 10. Encephalopathy not adequately controlled medically 11. Presence of medically uncontrolled ascites 12. Contraindications to MRI/CT (e.g. metal implants) 13. Allergy to contrast media that cannot be managed through prophylaxis 14. Contraindications to arteriography 15. Contraindications to the administration of cisplatin and adriamycin anticancer drugs 16. Contraindications to hepatic artery embolization 17. A person who is deemed difficult to conduct this clinical trial due to other reasons as judged by the test manager or test director

Design outcomes

Primary

MeasureTime frame
Pathologic necrosis

Secondary

MeasureTime frame
fattiodol accumulation;radiologic tumor response;post-embolization syndrome;liver function

Countries

Korea, Republic of

Contacts

Public ContactSori Park

Asan Medical Center

96sorisori@gmail.com+82-2-3010-2742

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026