UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016437 |
|---|---|
| Receipt number | R000019073 |
| Scientific Title | Clinical significance of serum procalcitonin and presepsin in patients with acute cholangitis |
| Date of disclosure of the study information | 2015/02/04 |
| Last modified on | 2018/08/08 20:12:56 |
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Basic information
Public title
Clinical significance of serum procalcitonin and presepsin in
patients with acute cholangitis
Acronym
Clinical significance of serum procalcitonin and presepsin in
patients with acute cholangitis
Scientific Title
Clinical significance of serum procalcitonin and presepsin in
patients with acute cholangitis
Scientific Title:Acronym
Clinical significance of serum procalcitonin and presepsin in
patients with acute cholangitis
Region
| Japan |
Condition
Condition
acute cholangitis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of diagnostic ability and therapeutic efficacy by procalcitonin and presepsin in patients with acute cholangitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
assessment of diagnostic ability and severity in patients with acute cholangitis
Key secondary outcomes
assessment of therapeutic efficacy in patients with acute cholangitis
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
Acute cholangitis
Requirement for Emergent ERCP
Ability to Obtain Written Informed Consent
Good performance status (ECGOG : 0-2)
Key exclusion criteria
Inability to perform ERCP
Inability to insertion of endoscopy
Severe other organ failuer
Inability to obtain informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Kitano |
Organization
Kinki University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Oasaka, Japan
TEL
072-366-0221
m-kitano@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Kitano |
Organization
Kinki University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Oasaka, Japan
TEL
072-366-0221
Homepage URL
m-kitano@med.kindai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation of Promotion of Science
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 02 | Month | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To measure serum procalcitonin and presenpsin in patinets with acute cholangitis.
Tocompare usefulness of serum procalcitonin and presepsin for diagnostic ability and severity of acute cholangitis
Management information
Registered date
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2018 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019073
| 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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| Registered date | File name |
