UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001669 |
|---|---|
| Receipt number | 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 09:27:56 |
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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
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
mtoshi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Japanese Society for Abdominal Emergency Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001720
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