Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a prospective, observational clinical trial designed to evaluate the feasibility, safety, and effectiveness of performing transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) using a transradial arterial approach. Traditionally, TACE procedures are performed through the femoral artery in the groin, but using the radial artery in the wrist may reduce complications, improve patient comfort, and allow for faster recovery.
In this study, eligible patients with unresectable HCC who meet the inclusion criteria-such as preserved liver function (Child-Pugh A), good performance status, and tumors of a certain size and number-will undergo TACE using HepaSphere drug-eluting embolic materials via radial access. No randomization or drug intervention will be assigned by protocol, as the treatment will follow standard clinical practice.
The study will follow participants for 12 months to assess technical success, tumor response using imaging criteria (mRECIST), safety outcomes including adverse events, and overall survival. The study is being conducted at Asan Medical Center in Seoul, Korea, and has received Institutional Review Board approval.
This is a prospective observational study to evaluate the feasibility, safety, and tumor response of transarterial chemoembolization (TACE) using a transradial approach in patients with hepatocellular carcinoma (HCC). Eligible patients will undergo drug-eluting beads TACE via radial access and be followed for up to 12 months. The primary outcome is the technical success rate of the procedure. Secondary outcomes include survival rate, tumor response by mRECIST, and adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE) group | Patients with hepatocellular carcinoma (HCC) who undergo transarterial chemoembolization (TACE) using a transradial arterial approach with HepaSphere microspheres. Participants will be observed prospectively to evaluate the technical success, safety, and tumor response following treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE) | Procedure | Transarterial chemoembolization performed through the radial artery using HepaSphere drug-eluting microspheres in patients with hepatocellular carcinoma. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success Rate | Defined as successful completion of the planned transarterial chemoembolization (TACE) procedure using transradial access without conversion to transfemoral access. | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rate Based on mRECIST | Assessed using modified RECIST (mRECIST) criteria by imaging studies. Includes complete response, partial response, stable disease, or progressive disease. | 1-3 months post-treatment |
| Incidence of Adverse Events |
Not provided
Inclusion Criteria:
-
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with hepatocellular carcinoma treated at Asan Medical Center, Seoul, Korea.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ji Hoon Shin, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-gu | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26070616 | Background | Fischman AM, Swinburne NC, Patel RS. A Technical Guide Describing the Use of Transradial Access Technique for Endovascular Interventions. Tech Vasc Interv Radiol. 2015 Jun;18(2):58-65. doi: 10.1053/j.tvir.2015.04.002. Epub 2015 Apr 11. |
Not provided
Not provided
The shared IPD will include anonymized clinical and laboratory results collected during the trial
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Number and type of adverse events observed following the TACE procedure. Severity will be graded using CTCAE criteria.
| Within 30 days of procedure |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |