UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014828 |
|---|---|
| Receipt number | 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 10:30:00 |
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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
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
ajiki@med.kobe-u.ac.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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017112
