UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006645
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kueno@kobeh.rofuku.go.jp

Sponsor
Institute kobe university
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007846

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.