UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013583 |
|---|---|
| Receipt number | R000015869 |
| Scientific Title | PTX3 in the assessment of severity and outcome of acute pancratitis |
| Date of disclosure of the study information | 2014/03/31 |
| Last modified on | 2018/09/10 18:07:49 |
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Basic information
Public title
PTX3 in the assessment of severity and outcome of acute pancratitis
Acronym
PTX3 in the assessment of severity and outcome of acute pancratitis
Scientific Title
PTX3 in the assessment of severity and outcome of acute pancratitis
Scientific Title:Acronym
PTX3 in the assessment of severity and outcome of acute pancratitis
Region
| Japan |
Condition
Condition
acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of PTX3 in assessment of severity and outcome of acute pancreatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Severity and outcome of acute pancreatitis between PTX3
Key secondary outcomes
PTX3 versus C-reactive protein
PTX3 versus procalcitonin
PTX3 with operation rate and motality rate
PTX3 with hospitalization
PTX3 with necrotising pancreatitis
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 acute pancreatitis in Saitama Medical Center, Saitama Medical University
Key exclusion criteria
except not patients with acute pancreatitis in Saitama Medical Center, Saitama Medical University
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Yakabi |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Gastroentelorogy and Hepatology
Zip code
Address
1981, Kamoda, Kawagoe, Saitama
TEL
049-228-3400
ryuichi5118@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichi Yamamoto |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Gastroentelorogy and Hepatology
Zip code
Address
1981, Kamoda, Kawagoe, Saitama
TEL
049-228-3400
Homepage URL
ryuichi5118@gmail.com
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 03 | Month | 31 | 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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
blood examination after 24 hours,48 hours,one week,two weeks, and four weeks on admission
Management information
Registered date
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015869
