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ID

27768

Description

Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture; ODM derived from: https://clinicaltrials.gov/show/NCT01320241

Link

https://clinicaltrials.gov/show/NCT01320241

Keywords

Versions (1)
  1. 11/28/17 11/28/17 -
Copyright Holder

See clinicaltrials.gov

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November 28, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Cholangiocellular Carcinoma NCT01320241

    English

    Eligibility Cholangiocellular Carcinoma NCT01320241

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age 18 years old or older
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures
    Description

    Malignant Biliary Obstruction Biopsy | Malignant Biliary Obstruction Operative Surgical Procedures

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3898473
    UMLS CUI [1,2]
    C0005558
    UMLS CUI [2,1]
    C3898473
    UMLS CUI [2,2]
    C0543467
    clinical symptoms of biliary obstruction
    Description

    Symptoms Biliary obstruction

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0400979
    unresectable or refused to be surgically treated biliary obstruction by any malignant process
    Description

    Malignant Biliary Obstruction unresectable | Malignant Biliary Obstruction Operative Surgical Procedures Refused

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3898473
    UMLS CUI [1,2]
    C1519810
    UMLS CUI [2,1]
    C3898473
    UMLS CUI [2,2]
    C0543467
    UMLS CUI [2,3]
    C1705116
    willing and able to comply with the study procedures and provide written informed consent to participate in the study
    Description

    Protocol Compliance | Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    UMLS CUI [2]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    suspected benign bile duct stricture
    Description

    Stricture of bile duct Suspected

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0235982
    UMLS CUI [1,2]
    C0750491
    strictures that can not be dilated enough to pass the delivery system
    Description

    Stricture Dilate procedure Insufficient | Other Coding

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1261287
    UMLS CUI [1,2]
    C1322279
    UMLS CUI [1,3]
    C0205412
    UMLS CUI [2]
    C3846158
    perforation of any duct within the biliary tree
    Description

    Perforation of bile duct

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0156218
    presence metallic biliary stent or bile duct surgery
    Description

    Bare-metal biliary stent Present | Bile duct Operative Surgical Procedures

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3876356
    UMLS CUI [1,2]
    C0150312
    UMLS CUI [2,1]
    C0005400
    UMLS CUI [2,2]
    C0543467
    patients for whom ptc procedures are contraindicated
    Description

    Medical contraindication Percutaneous transhepatic cholangiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0203085
    patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
    Description

    Hepatitis | Secondary malignant neoplasm of liver Involving Liver lobes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019158
    UMLS CUI [2,1]
    C0494165
    UMLS CUI [2,2]
    C1314939
    UMLS CUI [2,3]
    C0447541
    noncooperation or no authorization and signature
    Description

    Compliance behavior Lacking | Informed Consent Lacking

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0332268
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0332268
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    Similar models

    Eligibility Cholangiocellular Carcinoma NCT01320241

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age 18 years old or older
    boolean
    C0001779 (UMLS CUI [1])
    Malignant Biliary Obstruction Biopsy | Malignant Biliary Obstruction Operative Surgical Procedures
    Item
    biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures
    boolean
    C3898473 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    C3898473 (UMLS CUI [2,1])
    C0543467 (UMLS CUI [2,2])
    Symptoms Biliary obstruction
    Item
    clinical symptoms of biliary obstruction
    boolean
    C1457887 (UMLS CUI [1,1])
    C0400979 (UMLS CUI [1,2])
    Malignant Biliary Obstruction unresectable | Malignant Biliary Obstruction Operative Surgical Procedures Refused
    Item
    unresectable or refused to be surgically treated biliary obstruction by any malignant process
    boolean
    C3898473 (UMLS CUI [1,1])
    C1519810 (UMLS CUI [1,2])
    C3898473 (UMLS CUI [2,1])
    C0543467 (UMLS CUI [2,2])
    C1705116 (UMLS CUI [2,3])
    Protocol Compliance | Informed Consent
    Item
    willing and able to comply with the study procedures and provide written informed consent to participate in the study
    boolean
    C0525058 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Stricture of bile duct Suspected
    Item
    suspected benign bile duct stricture
    boolean
    C0235982 (UMLS CUI [1,1])
    C0750491 (UMLS CUI [1,2])
    Stricture Dilate procedure Insufficient | Other Coding
    Item
    strictures that can not be dilated enough to pass the delivery system
    boolean
    C1261287 (UMLS CUI [1,1])
    C1322279 (UMLS CUI [1,2])
    C0205412 (UMLS CUI [1,3])
    C3846158 (UMLS CUI [2])
    Perforation of bile duct
    Item
    perforation of any duct within the biliary tree
    boolean
    C0156218 (UMLS CUI [1])
    Bare-metal biliary stent Present | Bile duct Operative Surgical Procedures
    Item
    presence metallic biliary stent or bile duct surgery
    boolean
    C3876356 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    C0005400 (UMLS CUI [2,1])
    C0543467 (UMLS CUI [2,2])
    Medical contraindication Percutaneous transhepatic cholangiography
    Item
    patients for whom ptc procedures are contraindicated
    boolean
    C1301624 (UMLS CUI [1,1])
    C0203085 (UMLS CUI [1,2])
    Hepatitis | Secondary malignant neoplasm of liver Involving Liver lobes
    Item
    patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
    boolean
    C0019158 (UMLS CUI [1])
    C0494165 (UMLS CUI [2,1])
    C1314939 (UMLS CUI [2,2])
    C0447541 (UMLS CUI [2,3])
    Compliance behavior Lacking | Informed Consent Lacking
    Item
    noncooperation or no authorization and signature
    boolean
    C1321605 (UMLS CUI [1,1])
    C0332268 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C0332268 (UMLS CUI [2,2])
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