ID

40833

Description

Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01713244

Link

https://clinicaltrials.gov/show/NCT01713244

Keywords

Versions (2)
  1. 5/21/20 5/21/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 21, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01713244

English

Eligibility Hepatocellular Carcinoma NCT01713244

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of hcc confirmed at our hospital.
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
2. intrahepatic tumor count no higher than 3 and a minimum tumor diameter > 3 cm, but no more than 8cm.
Description

Tumor intrahepatic Count | Tumor Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1512948
UMLS CUI [1,3]
C0750480
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1301886
3. liver function of child-pugh class a or b.
Description

Liver function Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
4. tumors lacked intrahepatic and extrahepatic metastasis.
Description

Neoplasm Metastasis intrahepatic Lacking | Neoplasm Metastasis Extrahepatic Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1512948
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1517058
UMLS CUI [2,3]
C0332268
5. tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
Description

Tumor Cell Invasion Absent Portal vein | Tumor Cell Invasion Absent Trunk of hepatic vein | Tumor Cell Invasion Absent Branch of hepatic vein

Data type

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0032718
UMLS CUI [2,1]
C1269955
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1186314
UMLS CUI [3,1]
C1269955
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C1253959
UMLS CUI [3,4]
C0019155
6. indocyanine green retention at 15 minutes (icg-15) of <10%.
Description

Indocyanine Green Retention Minutes Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0021234
UMLS CUI [1,2]
C0333117
UMLS CUI [1,3]
C0439232
UMLS CUI [1,4]
C0439165
7. no evidence of coagulopathy: platelet count > 50 × 109/l and a prolonged prothrombin time of < 5 seconds.
Description

Blood Coagulation Disorders Absent | Platelet Count measurement | Prolonged prothrombin time

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0032181
UMLS CUI [3]
C2673577
8. no other anti-tumor therapy received before the treatment. -
Description

Cancer treatment Other Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients met the inclusion criteria but declined to participate.
Description

Study Subject Participation Status | Refusal to Participate

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1136454
2. patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
Description

Portal Hypertension Severe | Bleeding esophageal varices | Hypersplenism Severe | Refractory ascites

Data type

boolean

Alias
UMLS CUI [1,1]
C0020541
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0155789
UMLS CUI [3,1]
C0020532
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C3532188
3. patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.
Description

Pathology Permanent Post Therapy | Suggestive of Secondary malignant neoplasm of liver | Primary Malignant Liver Neoplasm Tissue type Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0677042
UMLS CUI [1,2]
C0205355
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0332299
UMLS CUI [2,2]
C0494165
UMLS CUI [3,1]
C0024620
UMLS CUI [3,2]
C2713035
UMLS CUI [3,3]
C0205394
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Similar models

Eligibility Hepatocellular Carcinoma NCT01713244

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
1. diagnosis of hcc confirmed at our hospital.
boolean
C2239176 (UMLS CUI [1])
Tumor intrahepatic Count | Tumor Diameter
Item
2. intrahepatic tumor count no higher than 3 and a minimum tumor diameter > 3 cm, but no more than 8cm.
boolean
C0027651 (UMLS CUI [1,1])
C1512948 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
Liver function Child-Pugh Classification
Item
3. liver function of child-pugh class a or b.
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Neoplasm Metastasis intrahepatic Lacking | Neoplasm Metastasis Extrahepatic Lacking
Item
4. tumors lacked intrahepatic and extrahepatic metastasis.
boolean
C0027627 (UMLS CUI [1,1])
C1512948 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C1517058 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Tumor Cell Invasion Absent Portal vein | Tumor Cell Invasion Absent Trunk of hepatic vein | Tumor Cell Invasion Absent Branch of hepatic vein
Item
5. tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
boolean
C1269955 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
C1269955 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1186314 (UMLS CUI [2,3])
C1269955 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1253959 (UMLS CUI [3,3])
C0019155 (UMLS CUI [3,4])
Indocyanine Green Retention Minutes Percentage
Item
6. indocyanine green retention at 15 minutes (icg-15) of <10%.
boolean
C0021234 (UMLS CUI [1,1])
C0333117 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Blood Coagulation Disorders Absent | Platelet Count measurement | Prolonged prothrombin time
Item
7. no evidence of coagulopathy: platelet count > 50 × 109/l and a prolonged prothrombin time of < 5 seconds.
boolean
C0005779 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C2673577 (UMLS CUI [3])
Cancer treatment Other Absent
Item
8. no other anti-tumor therapy received before the treatment. -
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Refusal to Participate
Item
1. patients met the inclusion criteria but declined to participate.
boolean
C2348568 (UMLS CUI [1])
C1136454 (UMLS CUI [2])
Portal Hypertension Severe | Bleeding esophageal varices | Hypersplenism Severe | Refractory ascites
Item
2. patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
boolean
C0020541 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0155789 (UMLS CUI [2])
C0020532 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C3532188 (UMLS CUI [4])
Pathology Permanent Post Therapy | Suggestive of Secondary malignant neoplasm of liver | Primary Malignant Liver Neoplasm Tissue type Other
Item
3. patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.
boolean
C0677042 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0332299 (UMLS CUI [2,1])
C0494165 (UMLS CUI [2,2])
C0024620 (UMLS CUI [3,1])
C2713035 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
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