UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003973
Receipt number 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 09:28:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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