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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014828
Receipt No. R000017112
Scientific Title Single arm clinical study of preoperative bile replacement for jaundiced patients : phase II traial to investigate the relationship to perioperative complication
Date of disclosure of the study information 2014/09/01
Last modified on 2019/02/13

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Basic information
Public title Single arm clinical study of preoperative bile replacement for jaundiced patients : phase II traial to investigate the relationship to perioperative complication
Acronym Phase II study of preoperative bile replacement
Scientific Title Single arm clinical study of preoperative bile replacement for jaundiced patients : phase II traial to investigate the relationship to perioperative complication
Scientific Title:Acronym Phase II study of preoperative 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 Investigate the effect of preoperative bile replacement for the patients with obstructive jaundice from the point of systemic and intestinal immunity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence of postoperative infectious complications
Key secondary outcomes Cellular immunity and intestinal integrity( Concanavalin A, Phytohemagglutin, Diamine oxydase activity)

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 0-1
Patients over 20 years of age to 80 years
Patients with Pancreas or biliary tract cancer without multiple organ failure.
Patients with serum total bilirubin levels greater than 3.0mg/dl.
Key exclusion criteria Patients who do not agree with this study.
Patients with cirrhosis or active hepatitis.
Patients with severe cardiac or respiratory disease.
Patients who receive hemodialysis.
Patients with pregnant.
Patients with cancer in other organs.
Patients who were deemed inappropriate by the attending physician.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Ajiki
Organization Kobe university hospital
Division name Hepato biliary pancreatic surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuouku Kobe-city
TEL 078-382-6302
Email ajiki@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuo Ajiki
Organization Kobe university hospital
Division name Hepato biliary pancreatic surgery
Zip code
Address 7-5-2 K7-5-2 Kusunoki-cho, Chuouku Kobe-city
TEL 078-382-6302
Homepage URL
Email ajiki@med.kobe-u.ac.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
2014 Year 09 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
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2018 Year 12 Month 28 Day
Date of closure to data entry
2018 Year 12 Month 28 Day
Date trial data considered complete
2018 Year 12 Month 28 Day
Date analysis concluded
2019 Year 12 Month 28 Day

Other
Other related information 1.Bile replacement; First, external biliary drainage(ENBD or PTBD) is performed as treatment of obstructive jaundice. Then, at least200ml of bile which is collected on the day before is taken orally for over 14 days.

2.Examination item;
Evaluation of the systemic immune function; concanavalin A, phytohemagglutinin.
Evaluation of intestinal integrity; serum diamine oxidase activity.
Evaluation of coagulate function; prothrombin time, activated partial thromboplastin time.
Evaluation of liver function; serum total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transpeptidase, cholinesterase.
Other items; volume of the drained bile, bilirubin concentration in the bile.

3.Postoperative surgical site infection; The diagnosis is made according to the CDC guideline.

Management information
Registered date
2014 Year 08 Month 11 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017112

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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