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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003973
Receipt No. R000004790
Scientific Title Validity of Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis in The Critical Patients with Hyperamylasemia
Date of disclosure of the study information 2010/08/01
Last modified on 2011/01/29

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Basic information
Public title Validity of Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis in The Critical Patients with Hyperamylasemia
Acronym Brief Title: Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis in Hyperamylasemia
Scientific Title Validity of Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis in The Critical Patients with Hyperamylasemia
Scientific Title:Acronym Brief Title: Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis in Hyperamylasemia
Region
Japan

Condition
Condition the critical patients with hyperamylasemia
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Emergency medicine
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this prospective study is to clarify the usefulness of urinary trypsinogen-2 for early diagnosis of acute pancreatitis in the critical patients with hyperamylasemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Evaluate the efficacy of urinary trypsinogen-2 test strip in the diagnosis, severity and prognosis of acute pancreatitis in the critical patients with hyperamylasemia.
Key secondary outcomes ((1) Evaluate the correlation of urinary trypsinogen-2 test strip and urinary trypsinogen-2 quantity test.
(2) Compare the efficacy of urinary trypsinogen-2 test strip in the diagnosis of acute pancreatitis with lipase in the critical patients with hyperamylasemia.
(3) Evaluate the correlation of urinary trypsinogen-2 test strip and severity and prognosis of acute pancreatitis in the critical patients with hyperamylasemia.
(4) Evaluate the correlation of urinary trypsinogen-2 test strip and urinary trypsinogen-2 quantity test in the cause of acute pancreatitis in the critical patients with hyperamylasemia.

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the critical patients with hyperamylasemia
Key exclusion criteria Participation in other study that is incompatible with this one.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Mayumi, M.D. & Ph.D.
Organization Nagoya University Graduate School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 65 Tsurumai, Showa,Nagoya, Aichi, 466-8560, Japan
TEL +81-52-744-2659
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Mayumi, M.D. & Ph.D.
Organization Nagoya University Graduate School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 65 Tsurumai, Showa, Nagoya, Aichi, 466-8560, Japan
TEL +81-52-744-2659
Homepage URL
Email mtoshi@med.nagoya-u.ac.jp

Sponsor
Institute Department of Emergency and Critical Care Medicine
Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization The Research Committee of Intractable Pancreatic Diseases (Principal investigator: Tooru Shimosegawa) provided by the Ministry of Health, Labour, and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 名古屋大学大学医学部附属病院 救急部、集中治療部(愛知県)、名古屋第二赤十字病院(愛知県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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 Completed
Date of protocol fixation
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2010 Year 10 Month 01 Day
Date trial data considered complete
2010 Year 11 Month 01 Day
Date analysis concluded
2010 Year 11 Month 01 Day

Other
Other related information We are adding the patients about presence or absence of pancreatitis onset, the subsequent course.

Management information
Registered date
2010 Year 07 Month 31 Day
Last modified on
2011 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004790

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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