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The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.
Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermediate embolization | Experimental | TACE with substatsis using gelfoam |
|
| Complete embolization | Active Comparator | TACE with complete embolization using gelfoam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermediate embolization | Procedure | TACE with substasis using gelfoam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate of the subjects | Survival rate of the subjects 6 months after TACE | 6 months after TACE |
| Survival rate of the subjects | Survival rate of the subjects, 12 months after TACE | 12 months after TACE |
| Survival rate of the subjects | Survival rate of the subjects, 18 months after TACE | 18 months after TACE |
| Survival rate of the subjects | Survival rate of the subjects, 24 months after TACE | 24 months after TACE |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival of the subjects | Disease free survival of the subjects, 24 months after TACE | 6, 12, 18, and 24 months after TACE |
| Complication rate of TACE | The incidence of infection, hemorrhage, 24 months after TACE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Hoon Park, M.D., Ph.D. | Contact | 82-2-829-5493 | dr.sanghoon.park@gmail.com | |
| Su Rin Shin, M.D. | Contact | 82-2-829-5490 | dr.goforit@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sang Hoon Park, M.D., Ph.D. | Hallym University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym Sacred Heart Hospital | Recruiting | Anyang | 431070 | South Korea |
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| Complete embolization | Procedure | TACE with complete embolization using gelfoam |
|
|
| 6, 12, 18, and 24 months after TACE |
| Chuncheon Sacred Heart Hospital | Recruiting | Chuncheon | 200060 | South Korea |
|
| Kangnam Sacred Heart Hostpita | Recruiting | Seoul | 150950 | South Korea |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D005781 | Gelatin Sponge, Absorbable |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D015503 | Surgical Sponges |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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