Inclusion criteria All Fulfill
Item
patients must meet all of the following inclusion criteria in order to be entered into the study:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Age
Item
1. age 18 or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. patient has signed informed consent
boolean
C0021430 (UMLS CUI [1])
Liver carcinoma
Item
3. patient must have a diagnosis of hepatocellular cancer confirmed by at least one of the following:
boolean
C2239176 (UMLS CUI [1])
Confirmed by Histology | Liver lesion Size Quantity MRI | Liver Cirrhosis | Hepatitis B, Chronic
Item
i. histological confirmation ii. magnetic resonance imaging (mri) result with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm. patient must also have evidence of cirrhosis or have chronic hepatitis b.
boolean
C0521093 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
C0577053 (UMLS CUI [2,1])
C0449453 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C0023890 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
Liver lesion Size Quantity CT with Contrast | Liver Cirrhosis | Hepatitis B, Chronic
Item
iii. contrast enhanced computed tomography (ct) with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1cm. patient must also have evidence of cirrhosis or have chronic hepatitis b.
boolean
C0577053 (UMLS CUI [1,1])
C0449453 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0742919 (UMLS CUI [1,4])
C0023890 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
Patient Inappropriate Excision | Patient Inappropriate Percutaneous Catheter Ablation
Item
d. patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0162560 (UMLS CUI [2,3])
Patient Inappropriate Ablation | Etiology Lesion Location
Item
patients not suitable for ablation due to lesion location may be enrolled
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0547070 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
Criteria Quantity Fulfill
Item
e. patient must meet at least one of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Child-Pugh Classification | Recurrent Hepatocellular Carcinoma | ECOG performance status
Item
i. stage child-pugh b 7 ii. recurrent hcc iii.performance status ecog 1
boolean
C4050412 (UMLS CUI [1])
C0861876 (UMLS CUI [2])
C1520224 (UMLS CUI [3])
Life Expectancy
Item
f. patient has a life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Absence Occlusive thrombus Main portal venous trunk
Item
g. absence of occlusive thrombus to the main portal trunk
boolean
C0332197 (UMLS CUI [1,1])
C0333203 (UMLS CUI [1,2])
C1183135 (UMLS CUI [1,3])
Criteria Any Fulfill
Item
if patients meet any of the following criteria they may not be entered into the study:
boolean
C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Chemotherapy | Therapeutic radiology procedure | sorafenib
Item
1. current or previous treatment with chemo- or radiation therapy or sorafenib
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1516119 (UMLS CUI [3])
Transarterial embolization Liver carcinoma
Item
2. previous treatment with any form of transarterial embolization for hcc
boolean
C3163695 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Cancer Other | Exception Skin carcinoma
Item
3. patients with current or history of any other cancer except non-melanomatous skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Absent
Item
4. female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
ECOG performance status
Item
5. performance status ecog > 2
boolean
C1520224 (UMLS CUI [1])
Child-Pugh - Total Score
Item
6. child-pugh scores >7
boolean
C4055253 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
7. active gastrointestinal bleeding
boolean
C0017181 (UMLS CUI [1])
Bleeding tendency | Correction Unsuccessful
Item
8. evidence of uncorrectable bleeding diathesis
boolean
C1458140 (UMLS CUI [1])
C1947976 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Liver carcinoma Spread Extrahepatic
Item
9. extra-hepatic spread of the hcc
boolean
C2239176 (UMLS CUI [1,1])
C0332261 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
Serum total bilirubin measurement
Item
10. total bilirubin > 3 mg/dl
boolean
C1278039 (UMLS CUI [1])
Liver Percentage Involvement with Tumor
Item
11. >50% tumor involvement of the liver
boolean
C0023884 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0027651 (UMLS CUI [1,4])
Liver carcinoma Infiltrating | Liver carcinoma Diffuse
Item
12. infiltrative or diffuse hcc
boolean
C2239176 (UMLS CUI [1,1])
C0332448 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0205219 (UMLS CUI [2,2])
Encephalopathy Poorly controlled
Item
13. encephalopathy not adequately controlled medically
boolean
C0085584 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Ascites Uncontrolled
Item
14. presence of ascites not controlled medically
boolean
C0003962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Focal Infection | Sepsis | Exception Hepatitis B | Exception Hepatitis C | Exception Hepatitis D | Exception Hepatitis E | Exception Hepatitis G
Item
15. presence of medically relevant localized or systemic infection, other than hepatitis b, c, d, e or g
boolean
C0016397 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0019196 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0011226 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0085293 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0814152 (UMLS CUI [7,2])
Medical contraindication MRI | Metallic implant
Item
16. any contraindication for mri (eg. metallic implants)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C3693688 (UMLS CUI [2])
Contrast media allergy | Prophylactic treatment Unsuccessful
Item
17. allergy to contrast media that cannot be managed with prophylaxis
boolean
C0570562 (UMLS CUI [1])
C0199176 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Hypersensitivity Iodized Oil
Item
18. allergy to iodized oil
boolean
C0020517 (UMLS CUI [1,1])
C0021972 (UMLS CUI [1,2])
Medical contraindication Arteriography
Item
19. any contraindication to arteriography
boolean
C1301624 (UMLS CUI [1,1])
C0003844 (UMLS CUI [1,2])
Medical contraindication Doxorubicin
Item
20. any contraindication for doxorubicin administration, including the following:
boolean
C1301624 (UMLS CUI [1,1])
C0013089 (UMLS CUI [1,2])
White Blood Cell Count procedure
Item
i. white blood cell count (wbc) <3000 cells/mm₃
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
ii. absolute neutrophil <1500 cells/mm₃
boolean
C0948762 (UMLS CUI [1])
Cardiac ejection fraction
Item
iii. cardiac ejection fraction <50%
boolean
C0232174 (UMLS CUI [1])
Exclusion Criteria Additional
Item
iv. other condition deemed exclusionary by physician
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Medical contraindication Hepatic embolisation
Item
u. any contraindication for hepatic embolization, including the following:
boolean
C1301624 (UMLS CUI [1,1])
C0744813 (UMLS CUI [1,2])
Portasystemic shunt | Arteriovenous fistula
Item
i. porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization
boolean
C0948900 (UMLS CUI [1])
C0003855 (UMLS CUI [2])
Hepatofugal flow
Item
ii. hepatofugal blood flow
boolean
C4086746 (UMLS CUI [1])
Creatinine measurement, serum
Item
iii. serum creatinine > 2mg/dl
boolean
C0201976 (UMLS CUI [1])
Clotting Impaired | Correction Unsuccessful
Item
iv. uncorrectable impaired clotting
boolean
C0005778 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1947976 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Platelet Count measurement
Item
1. platelet <50,000/mm₃
boolean
C0032181 (UMLS CUI [1])
International Normalized Ratio
Item
2. international normalized ratio (inr) > 1.4
boolean
C0525032 (UMLS CUI [1])
Activated Partial Thromboplastin Time measurement
Item
3. activated prothrombin time (aptt) less than 21 or greater than 40
boolean
C0030605 (UMLS CUI [1])
Aspartate aminotransferase increased
Item
v. ast > 5x upper limit of normal for lab
boolean
C0151904 (UMLS CUI [1])
Alanine aminotransferase increased
Item
vi. alt > 5x upper limit of normal for lab
boolean
C0151905 (UMLS CUI [1])