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

Uploaded on

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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