UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Rapid detection of bacterial infection for acute cholecystitis and cholangitis using multichannel gene autoanalyzer -prospective multicenter study-
Title of the study (Brief title)	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	Koji Asai
Organization	Toho University Ohashi Medical Center
Division name	Surgery
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	Koji Asai
Organization	Toho University Ohashi Medical Center
Division name	Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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