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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012843
Receipt No. R000014676
Scientific Title Liver stiffness measurement of before and after biliary drainage for patient with obstructive jaundice-A prospective cohort study
Date of disclosure of the study information 2014/01/14
Last modified on 2015/08/18

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Basic information
Public title Liver stiffness measurement of before and after biliary drainage for patient with obstructive jaundice-A prospective cohort study
Acronym Liver stiffness measurement for patient of obstructive jaundice
Scientific Title Liver stiffness measurement of before and after biliary drainage for patient with obstructive jaundice-A prospective cohort study
Scientific Title:Acronym Liver stiffness measurement for patient of obstructive jaundice
Region
Japan

Condition
Condition Obstructive jaundice
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate liver stiffness measurement for obstructive jaundice and effects of biliary drainage by Fibroscan and ARFI imaging.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Changes of Liver elasticity measurement (LEM) and Virtual Touch Tissue Quantification (VTTQ) associated with biliary drainage.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who had obstructive jaundice (T-Bil is over 2mg/dL) and scheduled for biliary drainage.
Key exclusion criteria 1) Patients who had diffuse liver disease by imaging test.
2) Patients who had acute cholangitis.
3) Impossible case of the measurement by abdominal ultrasound.
4) Patients who have a contraindication to endoscopic examination.
5) Pregnant women or women whom have possibility of pregnancy.
6) Patients who was judged inappropriate by chief (responsive) medical examiner.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kawakami
Organization Hokkaido University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-716-1161
Email hiropon@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kawakami
Organization Hokkaido University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-716-1161
Homepage URL
Email hiropon@med.hokudai.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information two weeks after registered

Management information
Registered date
2014 Year 01 Month 14 Day
Last modified on
2015 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014676

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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