UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012168 |
|---|---|
| Receipt number | R000012489 |
| Scientific Title | Evaluation for the efficacy of TAZ/PIPC for cholangitis after choledochojejunostomy |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2013/10/30 14:33:47 |
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Basic information
Public title
Evaluation for the efficacy of TAZ/PIPC for cholangitis after choledochojejunostomy
Acronym
Evaluation for the efficacy of TAZ/PIPC for cholangitis after choledochojejunostomy
Scientific Title
Evaluation for the efficacy of TAZ/PIPC for cholangitis after choledochojejunostomy
Scientific Title:Acronym
Evaluation for the efficacy of TAZ/PIPC for cholangitis after choledochojejunostomy
Region
| Japan |
Condition
Condition
cholangitis after choledocojejunostomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is intended to evaluate efficacy of TAZ/PIPC for cholangitis after choledochojejunostomy and compare with the efficacy of the carbapenem antibiotics prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
clinical effect
Key secondary outcomes
Bacteriological effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TAZ/PIPC
Interventions/Control_2
carbapenem antibiotics
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cholangitis after choledochojejunostomy
Key exclusion criteria
1) allergy for Penicillin
2) Infectious mononucleosis
3) Sodium valproate remedy
4) other therapy
5) pregnancy
6) severe cardiovascular, liver and renal disfunction
7) Past enrolled patients
8) severe mental disorder
9) others
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyoshi Toyokawa |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
Shinmachi 2-5-1, Hirakata city, Osaka, JAPAN
TEL
072-804-0101
toyokawh@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyoshi Toyokawa |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
Shinmachi 2-5-1, Hirakata city, Osaka, JAPAN
TEL
072-804-0101
Homepage URL
toyokawh@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2013 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 30 | Day |
Last modified on
| 2013 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012489
