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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004830
Receipt No. R000005750
Scientific Title Effect of delta-bilirubin on liver function during preoperative biliary drainage for obstructive jaundice
Date of disclosure of the study information 2011/02/01
Last modified on 2015/01/06

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Basic information
Public title Effect of delta-bilirubin on liver function during preoperative biliary drainage for obstructive jaundice
Acronym Delta-bilirubin and liver function during preoperative biliary drainage
Scientific Title Effect of delta-bilirubin on liver function during preoperative biliary drainage for obstructive jaundice
Scientific Title:Acronym Delta-bilirubin and liver function during preoperative biliary drainage
Region
Japan

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

Objectives
Narrative objectives1 To evaluate effects of delta-bilirubin on liver function during preoperative biliary drainage for obstructive jaundice
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Liver function tests during biliary drainage before surgery
Key secondary outcomes Postoperative 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are to undergo biliary drainage for obstructive jaundice
Key exclusion criteria Patients with underlying liver diseases
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email KOKUDO-2SU@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeaki Ishizawa
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address 7-3-1 Hongo, BUnkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email tish-tky@umin.ac.jp

Sponsor
Institute Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization Kanae Foundation for the Promotion of Medical Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Graduate School of Medicine, Shinshu University
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
2011 Year 02 Month 01 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 No longer recruiting
Date of protocol fixation
1997 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
1997 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Trends in results of liver function tests have been evaluated.

Management information
Registered date
2011 Year 01 Month 06 Day
Last modified on
2015 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005750

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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