ID

44100

Description

Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels; ODM derived from: https://clinicaltrials.gov/show/NCT00814242

Link

https://clinicaltrials.gov/show/NCT00814242

Keywords

Versions (2)
  1. 4/19/18 4/19/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00814242

English

Eligibility Hepatocellular Carcinoma NCT00814242

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
identify patients with hcc in accordance with the clinical diagnostic criteria of hcc passed at the chines eighth national live cancer academic conference. patients with hcc shall be diagnosed with pathology. there is at least one measurable lesion.
Description

Liver carcinoma | Measurable Lesion Quantity

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
hepatoma involved in this research at complex site is located at the eighth segment of liver, the substantial depth of liver below hepatic integument adjacent to the trunk of inferior vena cava, hepatic vein and portal vein. the tumor is located at hepatic caudate lobe. the maximal diameter < or=3m, ajcc/uicc—tnm stage is stage ii and above. lesions are determined by three senior hepatobiliary experts independently, therefore radical resection is possible. there is no possibility of extra-hepatic metastasis and tumor thrombus of portal vein, hepatic vein, vena cava and bile duct.
Description

Hepatoma Involved Location Liver segment | Tumor Location Caudate lobe of liver | Tumor Diameter Size | Tumor TNM clinical staging | Lesion Determination | Radical excision Possible | Absence Neoplasm Metastasis Extrahepatic | Absence Tumor Thrombus Portal vein | Absence Tumor Thrombus Hepatic vein | Absence Tumor Thrombus Vena cava | Absence Tumor Thrombus Bile duct

Data type

boolean

Alias
UMLS CUI [1,1]
C0023903
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C0457138
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0227489
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0456389
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C3258246
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C1148554
UMLS CUI [6,1]
C0184918
UMLS CUI [6,2]
C0332149
UMLS CUI [7,1]
C0332197
UMLS CUI [7,2]
C0027627
UMLS CUI [7,3]
C1517058
UMLS CUI [8,1]
C0332197
UMLS CUI [8,2]
C0027651
UMLS CUI [8,3]
C0087086
UMLS CUI [8,4]
C1305775
UMLS CUI [9,1]
C0332197
UMLS CUI [9,2]
C0027651
UMLS CUI [9,3]
C0087086
UMLS CUI [9,4]
C0019155
UMLS CUI [10,1]
C0332197
UMLS CUI [10,2]
C0027651
UMLS CUI [10,3]
C0087086
UMLS CUI [10,4]
C1280190
UMLS CUI [11,1]
C0332197
UMLS CUI [11,2]
C0027651
UMLS CUI [11,3]
C0087086
UMLS CUI [11,4]
C0005400
criteria of liver function: child a level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. it's appropriate to perform liver resection and minimally invasive treatment.
Description

Liver function | Child-Pugh Classification | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Hepatectomy Appropriateness | Minimally Invasive Surgical Procedures Appropriateness

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C4050412
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
UMLS CUI [6,1]
C0019144
UMLS CUI [6,2]
C0814634
UMLS CUI [7,1]
C0282624
UMLS CUI [7,2]
C0814634
no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal.
Description

Absence Dysfunction Organ Major | Hematologic function | Renal function | Cardiac function | Pulmonary function

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C3887504
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0205164
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232164
UMLS CUI [5]
C0231921
patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.
Description

Age | Volunteer | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1997894
UMLS CUI [3]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may affect the treatment of liver cancer.
Description

Cardiac dysfunction Affecting Therapy Liver cancer | Pulmonary Dysfunction Affecting Therapy Liver cancer | Brain dysfunction Affecting Therapy Liver cancer | Renal dysfunction Affecting Therapy Liver cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C3277906
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0345904
UMLS CUI [2,1]
C1709770
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0345904
UMLS CUI [3,1]
C0262405
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C0345904
UMLS CUI [4,1]
C3279454
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0345904
patients with other diseases which may affect the treatment mentioned here.
Description

Disease Affecting Clinical Trial Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0087111
patients with medical history of other malignant tumors.
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
subjects participating in other clinical trials.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
women in pregnancy and breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with tumor ajcc/uicc—tnm stage at iiia period or below.
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
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Similar models

Eligibility Hepatocellular Carcinoma NCT00814242

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Measurable Lesion Quantity
Item
identify patients with hcc in accordance with the clinical diagnostic criteria of hcc passed at the chines eighth national live cancer academic conference. patients with hcc shall be diagnosed with pathology. there is at least one measurable lesion.
boolean
C2239176 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Hepatoma Involved Location Liver segment | Tumor Location Caudate lobe of liver | Tumor Diameter Size | Tumor TNM clinical staging | Lesion Determination | Radical excision Possible | Absence Neoplasm Metastasis Extrahepatic | Absence Tumor Thrombus Portal vein | Absence Tumor Thrombus Hepatic vein | Absence Tumor Thrombus Vena cava | Absence Tumor Thrombus Bile duct
Item
hepatoma involved in this research at complex site is located at the eighth segment of liver, the substantial depth of liver below hepatic integument adjacent to the trunk of inferior vena cava, hepatic vein and portal vein. the tumor is located at hepatic caudate lobe. the maximal diameter < or=3m, ajcc/uicc—tnm stage is stage ii and above. lesions are determined by three senior hepatobiliary experts independently, therefore radical resection is possible. there is no possibility of extra-hepatic metastasis and tumor thrombus of portal vein, hepatic vein, vena cava and bile duct.
boolean
C0023903 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0457138 (UMLS CUI [1,4])
C0027651 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0227489 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0456389 (UMLS CUI [3,3])
C0027651 (UMLS CUI [4,1])
C3258246 (UMLS CUI [4,2])
C0221198 (UMLS CUI [5,1])
C1148554 (UMLS CUI [5,2])
C0184918 (UMLS CUI [6,1])
C0332149 (UMLS CUI [6,2])
C0332197 (UMLS CUI [7,1])
C0027627 (UMLS CUI [7,2])
C1517058 (UMLS CUI [7,3])
C0332197 (UMLS CUI [8,1])
C0027651 (UMLS CUI [8,2])
C0087086 (UMLS CUI [8,3])
C1305775 (UMLS CUI [8,4])
C0332197 (UMLS CUI [9,1])
C0027651 (UMLS CUI [9,2])
C0087086 (UMLS CUI [9,3])
C0019155 (UMLS CUI [9,4])
C0332197 (UMLS CUI [10,1])
C0027651 (UMLS CUI [10,2])
C0087086 (UMLS CUI [10,3])
C1280190 (UMLS CUI [10,4])
C0332197 (UMLS CUI [11,1])
C0027651 (UMLS CUI [11,2])
C0087086 (UMLS CUI [11,3])
C0005400 (UMLS CUI [11,4])
Liver function | Child-Pugh Classification | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Hepatectomy Appropriateness | Minimally Invasive Surgical Procedures Appropriateness
Item
criteria of liver function: child a level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. it's appropriate to perform liver resection and minimally invasive treatment.
boolean
C0232741 (UMLS CUI [1])
C4050412 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0019144 (UMLS CUI [6,1])
C0814634 (UMLS CUI [6,2])
C0282624 (UMLS CUI [7,1])
C0814634 (UMLS CUI [7,2])
Absence Dysfunction Organ Major | Hematologic function | Renal function | Cardiac function | Pulmonary function
Item
no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal.
boolean
C0332197 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0221130 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
C0231921 (UMLS CUI [5])
Age | Volunteer | Informed Consent
Item
patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.
boolean
C0001779 (UMLS CUI [1])
C1997894 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Cardiac dysfunction Affecting Therapy Liver cancer | Pulmonary Dysfunction Affecting Therapy Liver cancer | Brain dysfunction Affecting Therapy Liver cancer | Renal dysfunction Affecting Therapy Liver cancer
Item
patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may affect the treatment of liver cancer.
boolean
C3277906 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0345904 (UMLS CUI [1,4])
C1709770 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0345904 (UMLS CUI [2,4])
C0262405 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0345904 (UMLS CUI [3,4])
C3279454 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0345904 (UMLS CUI [4,4])
Disease Affecting Clinical Trial Therapy
Item
patients with other diseases which may affect the treatment mentioned here.
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Cancer Other
Item
patients with medical history of other malignant tumors.
boolean
C1707251 (UMLS CUI [1])
Study Subject Participation Status
Item
subjects participating in other clinical trials.
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
women in pregnancy and breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
TNM clinical staging
Item
patients with tumor ajcc/uicc—tnm stage at iiia period or below.
boolean
C3258246 (UMLS CUI [1])
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