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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001669
Receipt No. R000001720
Scientific Title Validity of Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis -Multi-Center Study -
Date of disclosure of the study information 2009/01/29
Last modified on 2011/01/29

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Basic information
Public title Validity of Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis -Multi-Center Study -
Acronym Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis
Scientific Title Validity of Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis -Multi-Center Study -
Scientific Title:Acronym Urine trypsinogen-2 in Diagnosis of Acute Pancreatitis
Region
Japan

Condition
Condition The patient with abdominal pain that may have acute pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate utility of in the diagnosis of acute pancreatits with trypsinogen-2 test strip.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate accuracy of trypsinogen-2 test strip in the diagnosis of acute pancreatits.
Key secondary outcomes (1) Correlation of value of urine trypsinogen-2 and trypsinogen-2 test strip in the diagnosis of acute pancreatits.
(2) Comparison with serum amylase and lipase with trypsinogen-2 test strip in the diagnosis of acute pancreatits.
(3) Correlation of urine trypsinogen-2 strip test and severity of acute pancreatits.
(4) Correlation of value of urine trypsinogen-2 strip and severity of acute pancreatits.
(5) Accuracy of with urine trypsinogen-2 test strip and value of urine trypsinogen-2 in the diagnosis of acute pancreatits depending causing clinical condition.

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 Definite or possible acute pancreatitis
Key exclusion criteria Participation in other study that is incompatible with this one
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadahiro Takada
Organization Teikyo University
Division name Department of Surgery
Zip code
Address 2-11-1 Kaga, Itabashi, Tokyo, 173-8606, Japan
TEL 02-3964-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Mayumi
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 052-744-2659
Homepage URL
Email mtoshi@med.nagoya-u.ac.jp

Sponsor
Institute Japanese Society for Abdominal Emergency Medicine
Institute
Department

Funding Source
Organization Japanese Society for Abdominal Emergency Medicine
Organization
Division
Category of Funding Organization Self funding
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 札幌医科大学 (北海道)
市立秋田総合病院 (秋田県)
東北大学 (宮城県)
帝京大学 (東京都)
聖路加国際病院 (東京都)
東京医科大学 (東京都)
東邦大大橋病院 (東京都)
君津中央病院 (千葉県)
横浜市立大学市民総合医療センター高度救命救急センター (神奈川県)
聖マリアンナ横浜西部病院 (神奈川県)
福井大学 (福井県)
名古屋大学 (愛知県)
名古屋掖済会病院 (愛知県)
藤田保健衛生第2教育(坂文種) (愛知県)
名古屋第2日赤 (愛知県)
大垣市民病院 (岐阜県)
岐阜大学 (岐阜県)
三重大学 (三重県)
蘇生会総合病院 (京都府)
広島市立安佐市民病院 (広島県)
広島赤十字病院 (広島県)
福岡大学 (福岡県)
久留米大学 (福岡県)
鹿児島市医師会病院 (鹿児島県)

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 29 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
2007 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2009 Year 05 Month 01 Day
Date of closure to data entry
2009 Year 05 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2009 Year 09 Month 01 Day

Other
Other related information Primary end point: (1) Evaluate the efficacy of urinary trypsinogen-2 test strip in the diagnosis of acute pancreatitis.
Secondary end point: (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 serum amylase and lipase.
(3) Evaluate the correlation of urinary trypsinogen-2 test strip and severity and prognosis of acute pancreatitis.
(4) Evaluate the correlation of urinary trypsinogen-2 quantity test and severity and prognosis of acute pancreatitis.
(5) Evaluate the correlation of urinary trypsinogen-2 test strip and urinary trypsinogen-2 quantity test in the cause of acute pancreatitis.

Management information
Registered date
2009 Year 01 Month 29 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=R000001720

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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