About this trial
The purpose of this study was to prospectively collect clinical data from patients who underwent hepatic artery chemoembolization using microspheres with different degradation times (2 hours, 1 day, 2 weeks) based on standard treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 19 to 79 years
Patient who signed Informed Consent Form
Patients diagnosed with hepatocellular carcinoma by American Association for the Study of Liver Diseases (AASLD) and at least one of the following methods i. Magnetic resonance imaging (MRI) with early augmentation and delayed excretion of at least one solid liver lesion greater than 1 ㎝.
Patients should not be eligible for treatment by amputation or percutaneous resection or liver transplantation at the time of study enrollment.
Disqualifiers
Patients under the age of 19
Chronic kidney disease (CDK) grade 4 or 5 patients
Current or previous treatment with chemotherapy or radiation therapy or sorafenib or drug release chemoembolization (deTACE) after diagnosis of hepatocellular carcinoma
Extensive context-to-systemic shunts
Trial design
Single group
Treatments tested in this trial
Nexsphere™
DeviceNexsphere™ is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postembolism syndrome
Nausea, vomiting, persistent pain, fever, and other
Incidence of liver function impairment
AFP, AST, ALT, BILI, GGT, BUN, and CREAT level
Secondary outcomes
Tumor treatment response
Evaluation of tumor size by Magnetic Resonance Imaging or Computed Tomography scan at 4 and 8 weeks after embolization
Hepatic artery damage
Vessel dissection, vessel stenosis, vessel occlusion, vessel wall irregularity, and other
Sponsors and contacts
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