UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004830 |
|---|---|
| Receipt number | 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 09:05:12 |
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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
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
tish-tky@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005750
