UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Role of Serum Procalcitonin in Diagnosis and Management of Biliary Tract Infection
Title of the study (Brief title)	Role of Serum Procalcitonin in Diagnosis and Management of Biliary Tract Infection
Region	Japan

Condition
Condition	Biliary tract infection
Classification by specialty	Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study 1. To evaluate the efficacy of procalcitonin in the diagnosis and severity assessment of biliary tract infection. Study 2. To evaluate the role of procalcitonin as a predictor of efficacy of treatment for biliary tract infection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Study 1. To determine the cut-off value of serum procalcitonin in the diagnosis and severity assessment of biliary tract infection. Study 2. To examine the correlation between time to defervescence and serum procalcitonin value in patients with biliary tract infection.
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Study 1. Patients with acute cholangitis, acute cholecystitis, or liver abscess, who started antibiotic therapy at the time of admission. Study 2. Patients with acute cholangitis, acute cholecystitis, or liver abscess, who started antibiotic therapy at the time of admission and who received endoscopic or percutaneous drainage. Patients with written informed consent.
Key exclusion criteria	1) Patients with other active concomitant infections. 2) Patients considered ineligible for this study.
Target sample size	500

Research contact person
Name of lead principal investigator	Hirofumi Kogure
Organization	Faculty of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	kogureh-tky@umin.ac.jp

Public contact
Name of contact person	Hirofumi Kogure
Organization	Faculty of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	kogureh-tky@umin.ac.jp

Sponsor
Institute	Faculty of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 03 Month 11 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 03 Month 08 Day
Anticipated trial start date	2013 Year 03 Month 11 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	Published
URL releasing results
Results
Other related information	Study 1. Serum procalcitonin value at the time of admission. Study 2. Sequential change of serum procalcitonin value before and after treatment.

Management information
Registered date	2013 Year 03 Month 10 Day
Last modified on	2017 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011943