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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013583
Receipt No. 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

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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
Email 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
Email ryuichi5118@gmail.com

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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