UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030445 |
|---|---|
| Receipt number | R000034761 |
| Scientific Title | Rapid detection of bacterial infection for acute cholecystitis and cholangitis using multichannel gene autoanalyzer -prospective multicenter study- |
| Date of disclosure of the study information | 2017/12/19 |
| Last modified on | 2017/12/18 12:47:50 |
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Basic information
Public title
Rapid detection of bacterial infection for acute cholecystitis and cholangitis using multichannel gene autoanalyzer -prospective multicenter study-
Acronym
Rapid detection of bacterial infection
Scientific Title
Rapid detection of bacterial infection for acute cholecystitis and cholangitis using multichannel gene autoanalyzer -prospective multicenter study-
Scientific Title:Acronym
Rapid detection of bacterial infection
Region
| Japan |
Condition
Condition
acute cholecystitis and cholangitis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will performed to detect rapid bacterial infection for acute cholecystitis and cholangitis using the multichannel gene autoanalyzer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
accuracy of detection of bacterial infection, detection time
Key secondary outcomes
detection rate of bacterial infection
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
more than 20 years old
Acute cholecystitis and cholangitis
Key exclusion criteria
No informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Asai |
Organization
Toho University Ohashi Medical Center
Division name
Surgery
Zip code
Address
2-17-6 Ohashi, Meguro-ku, Tokyo
TEL
03-3468-1251
k-asai@mvg.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Asai |
Organization
Toho University Ohashi Medical Center
Division name
Surgery
Zip code
Address
2-17-6 Ohashi, Meguro-ku, Tokyo
TEL
03-3468-1251
Homepage URL
k-asai@mvg.biglobe.ne.jp
Sponsor or person
Institute
Department of Surgery, Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Toho University Ohashi Medical Center
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
| 2017 | Year | 12 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ongoing
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2017 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034761
