UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012843
Receipt number 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 13:32:28

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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 or person

Institute

Department of Gastroenterology and Hepatology, Hokkaido University Hospital

Institute

Department

Personal name



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

Value
https://center6.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