UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010202 |
|---|---|
| Receipt number | R000011943 |
| Scientific Title | Role of Serum Procalcitonin in Diagnosis and Management of Biliary Tract Infection |
| Date of disclosure of the study information | 2013/03/11 |
| Last modified on | 2017/09/12 11:19:26 |
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Basic information
Public title
Role of Serum Procalcitonin in Diagnosis and Management of Biliary Tract Infection
Acronym
Role of Serum Procalcitonin in Diagnosis and Management of Biliary Tract Infection
Scientific Title
Role of Serum Procalcitonin in Diagnosis and Management of Biliary Tract Infection
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kogure |
Organization
Faculty of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kogureh-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kogure |
Organization
Faculty of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
kogureh-tky@umin.ac.jp
Sponsor or person
Institute
Faculty of Medicine, The University of Tokyo
Institute
Department
Personal name
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)
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 | 03 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 08 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011943
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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