UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008618 |
|---|---|
| Receipt number | R000010130 |
| Scientific Title | Evaluation of Efficacy of Serum Procalcitonin Measurements in the Clinical Management of Acute Cholangitis |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2017/02/08 18:25:44 |
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Basic information
Public title
Evaluation of Efficacy of Serum Procalcitonin Measurements in the Clinical Management of Acute Cholangitis
Acronym
Efficacy of Procalcitonin in the Clinical Management of Acute Cholangitis
Scientific Title
Evaluation of Efficacy of Serum Procalcitonin Measurements in the Clinical Management of Acute Cholangitis
Scientific Title:Acronym
Efficacy of Procalcitonin in the Clinical Management of Acute Cholangitis
Region
| Japan |
Condition
Condition
Patients with cholestasis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the efficacy of serum procalcitonin measurements in diagnosis and severity assessment of acute cholangitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To set up the cut-off value of serum procalcitonin level in the diagnosis of acute cholangitis
2. To set up the cut-off value of serum procalcitonin level in the severitiy assessment of acute cholangitis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cholestasis due to choledocholithiasis, pancreato-biliary malignancy, and benign bile duct stricture
Key exclusion criteria
Patients with acute cholecystitis, hepatic abscess, acute pancreatitis, recurrence of cancer, liver cirrhosis, chronic kidney disease, and chronic obstructive pulmonary disease and patients receiving long term steroid treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiko Miura |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihiko Miura |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
Homepage URL
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Sceience and Technology
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
| 2012 | Year | 08 | Month | 06 | 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
| 2012 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observation study
Management information
Registered date
| 2012 | Year | 08 | Month | 04 | Day |
Last modified on
| 2017 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010130
