UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006645 |
|---|---|
| Receipt number | R000007846 |
| Scientific Title | Evaluation of Schedule of bile replacement for obstructive jaundice |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2014/12/22 12:04:02 |
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Basic information
Public title
Evaluation of Schedule of bile replacement for obstructive jaundice
Acronym
Evaluation of Schedule of bile replacement
Scientific Title
Evaluation of Schedule of bile replacement for obstructive jaundice
Scientific Title:Acronym
Evaluation of Schedule of bile replacement
Region
| Japan |
Condition
Condition
Biliary tract cancer and pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the schedule of effective bile replacement for obstructive jaundice
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
peripheral blood, coagulation, liver function,
concanavaline A, PHA, VitaminK
Key secondary outcomes
Diamine oxydase, fatty acid
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Performance Status 0 or 1
Patients over 20 years of age to 80 years
Pancreaticobiliary tract cancer patients without multiple organ failure
Patients with serum total bilirubin levels greater than 5.0mg/dl, direct bilirubin levels greater than 3.0mg/dl
Key exclusion criteria
Patients who do not agree this study
Patients deemed inappropriate by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ueno Kimihiko |
Organization
Kobe University
Division name
hepatobiliary pancreatic surgery
Zip code
Address
7-5-2 Kusunoki-cho Chuouku Kobe-city
TEL
078-382-6302
kueno@kobeh.rofuku.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ueno Kimihiko |
Organization
Kobe University
Division name
hepatobiliary pancreatic surgery
Zip code
Address
7-5-2 Kusunoki-cho Chuouku Kobe-city
TEL
078-382-6302
Homepage URL
kueno@kobeh.rofuku.go.jp
Sponsor or person
Institute
kobe university
Institute
Department
Personal name
Funding Source
Organization
Kobe university division of Hepato-biliary-pancreatic surgery
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
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
神戸大学附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | 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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 01 | Day |
Other
Other related information
bile return
As treatment for obstructive jaundice, external biliary drainage (PTBD or ENBD) is performed, then 200ml of bile which was collected previous day was taken by mouth (100ml AM, 100ml PM).
Inspection item
To evaluate the systemic immune peripheral blood, white blood cell fraction, ConcanavalinA, Phytohemagglutinin, fatty acid analysis, as the evaluation of DAO activity of intestinal immunity, coagulation vitamin K as an assessment, PT, APTT, T as the evaluation of liver function-Bil, D-Bil, AST, ALT, ALP, gamma GTP, CHE, FFA, phospholipids measured.
Further blood count is eight times(before drainage, after drainage, and day1, 2, 3, 5, 8, 12, after bile replacement begin), and blood volume is 25ml once.
Management information
Registered date
| 2011 | Year | 11 | Month | 01 | Day |
Last modified on
| 2014 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007846
