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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030445
Receipt No. 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

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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
Email 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
Email k-asai@mvg.biglobe.ne.jp

Sponsor
Institute Department of Surgery, Toho University Ohashi Medical Center
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034761

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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