ID

43986

Description

Pilot Study of Percutaneous Irreversible Electroporation to Treat Unresectable Hepatic Carcinoma Close to the Gallbladder; ODM derived from: https://clinicaltrials.gov/show/NCT02332551

Link

https://clinicaltrials.gov/show/NCT02332551

Keywords

Versions (2)
  1. 5/23/16 5/23/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatic Carcinoma NCT02332551

English

Eligibility Hepatic Carcinoma NCT02332551

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
Description

Liver carcinoma | Biopsy Positive | criteria Non-invasive

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C1446409
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C0205303
tumor from gallbladder is ＜0.5 cm
Description

gallbladder neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0016978
not suitable for surgical resection or transplantation,
Description

Operative Surgical Procedures Inappropriate | Transplantation Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C1548788
have at least one, but less than or equal to 3 tumors,
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
of the tumour(s) identified, each tumor must be ≤ 7 cm in diameter,
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C1301886
child-pugh class a,b
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C4050412
eastern cooperative oncology group (ecog) score of 0-1,
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
american society of anaesthesiologists (asa) score ≤ 3,
Description

American Society of Anesthesiologists physical status classification

Data type

boolean

Alias
UMLS CUI [1]
C0450990
a prothrombin time ratio > 50%,
Description

Prothrombin time ratio

Data type

boolean

Alias
UMLS CUI [1]
C0483455
platelet count > 80x109/l,
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure,
Description

Anticoagulant therapy Ability Treatment Termination | Antiplatelet therapy Ability Treatment Termination | Irreversible electroporation system

Data type

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0871548
UMLS CUI [2,1]
C1096021
UMLS CUI [2,2]
C0085732
UMLS CUI [2,3]
C0871548
UMLS CUI [3]
C3876171
are able to comprehend and willing to sign the written informed consent form (icf),
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
have a life expectancy of at least 3 months.
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
eligible for surgical treatment or transplantation for hcc,
Description

Liver carcinoma Operative Surgical Procedures eligible | Liver carcinoma Transplantation eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C1548635
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0040732
UMLS CUI [2,3]
C1548635
hepatic carcinoma developed on an already transplanted liver,
Description

Liver carcinoma Transplanted liver

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1280833
cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
Description

Heart failure | Coronary Artery Disease Continuous | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0549178
UMLS CUI [3]
C0003811
any active implanted device (eg pacemaker),
Description

Implants | Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0021102
UMLS CUI [2]
C0030163
women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
Description

Pregnancy Contraceptive methods Absent | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.
Description

Therapeutic procedure Investigational New Drugs | Therapeutic procedure Irreversible electroporation system | Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3876171
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
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Similar models

Eligibility Hepatic Carcinoma NCT02332551

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Biopsy Positive | criteria Non-invasive
Item
hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
boolean
C2239176 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0243161 (UMLS CUI [3,1])
C0205303 (UMLS CUI [3,2])
gallbladder neoplasm
Item
tumor from gallbladder is ＜0.5 cm
boolean
C0016978 (UMLS CUI [1])
Operative Surgical Procedures Inappropriate | Transplantation Inappropriate
Item
not suitable for surgical resection or transplantation,
boolean
C0543467 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0040732 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Malignant Neoplasms
Item
have at least one, but less than or equal to 3 tumors,
boolean
C0006826 (UMLS CUI [1])
ID.5
Item
of the tumour(s) identified, each tumor must be ≤ 7 cm in diameter,
boolean
C0006826 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Child-Pugh Classification
Item
child-pugh class a,b
boolean
C4050412 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score of 0-1,
boolean
C1520224 (UMLS CUI [1])
American Society of Anesthesiologists physical status classification
Item
american society of anaesthesiologists (asa) score ≤ 3,
boolean
C0450990 (UMLS CUI [1])
Prothrombin time ratio
Item
a prothrombin time ratio > 50%,
boolean
C0483455 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 80x109/l,
boolean
C0032181 (UMLS CUI [1])
Anticoagulant therapy Ability Treatment Termination | Antiplatelet therapy Ability Treatment Termination | Irreversible electroporation system
Item
ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure,
boolean
C0150457 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0871548 (UMLS CUI [1,3])
C1096021 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
C0871548 (UMLS CUI [2,3])
C3876171 (UMLS CUI [3])
Informed consent
Item
are able to comprehend and willing to sign the written informed consent form (icf),
boolean
C0021430 (UMLS CUI [1])
Life expectancy
Item
have a life expectancy of at least 3 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver carcinoma Operative Surgical Procedures eligible | Liver carcinoma Transplantation eligible
Item
eligible for surgical treatment or transplantation for hcc,
boolean
C2239176 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
C1548635 (UMLS CUI [2,3])
Liver carcinoma Transplanted liver
Item
hepatic carcinoma developed on an already transplanted liver,
boolean
C2239176 (UMLS CUI [1,1])
C1280833 (UMLS CUI [1,2])
Heart failure | Coronary Artery Disease Continuous | Cardiac Arrhythmia
Item
cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
boolean
C0018801 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3])
Implants | Artificial cardiac pacemaker
Item
any active implanted device (eg pacemaker),
boolean
C0021102 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
Pregnancy Contraceptive methods Absent | Childbearing Potential Contraceptive methods Absent
Item
women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
boolean
C0032961 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Therapeutic procedure Investigational New Drugs | Therapeutic procedure Irreversible electroporation system | Compliance behavior Limited
Item
have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.
boolean
C0087111 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C3876171 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
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