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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002552
Receipt No. R000003000
Scientific Title Diagnostic criteria and severity assessment in acute cholangitis: A prospective observational study
Date of disclosure of the study information 2009/09/28
Last modified on 2010/03/29

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Basic information
Public title Diagnostic criteria and severity assessment in acute cholangitis: A
prospective observational study
Acronym
Diagnostic criteria and severity assessment in acute cholangitis
(CLASS Tokyo)
Scientific Title Diagnostic criteria and severity assessment in acute cholangitis: A
prospective observational study
Scientific Title:Acronym
Diagnostic criteria and severity assessment in acute cholangitis
(CLASS Tokyo)
Region
Japan Asia(except Japan)

Condition
Condition Acute cholangitis
Classification by specialty
Hepato-biliary-pancreatic medicine Infectious disease Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Diagnostic criteria and severity assessment in acute cholangitis: A
prospective observational study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic assessment in acute cholangitis
Severity assessment in acute cholangitis
Rate of mortality and organ failures in acute cholangitis
Key secondary outcomes Prognostic factors of acute cholangitis
Etiologies of acute cholangitis
Drainage methods of acute cholangitis
Antibiotics

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 cholangitis
Key exclusion criteria 1, Patients with other active inflammatory diseases such as acute cholecystitis
2, Patients inappropriate for participating to this study decided by the attending physicians
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadahiro TAKADA
Organization Teikyo University School of Medicine
Division name Surgery
Zip code
Address 2-11-1 Kaga Itabashi-ku Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshio TSUYUGUCHI
Organization Graduate School of Medicine Chiba University
Division name Department of Medicine and Clinical Oncology
Zip code
Address
TEL
Homepage URL http://class.umin.jp/
Email

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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 帝京大学病院(東京都)
国際医療福祉大学臨床医学研究センター化研病院(千葉県)
千葉大学医学部附属病院(千葉県)
国保旭中央病院(千葉県)
手稲渓仁会病院(北海道)
亀田総合病院(千葉県)
東京女子医科大学八千代病院(千葉県)
熊谷総合病院(埼玉県)
キッコーマン総合病院(千葉県)
千葉県がんセンター(千葉県)
下都賀総合病院(栃木県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 28 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 Enrolling by invitation
Date of protocol fixation
2008 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information For the primary endpoints, we will assess sensitivity, specificity and accuracy of Tokyo guidelines in diagnosing acute cholangitis.
For the secondary endpoints, prognostic factors (body temperature, pulse rate, total bilirubin, serum creatinie, serum albumin, platelets, methods of biliary drainage, used antimicrobial agents, etiologies of cholangitis, etc.) for acute cholangitis will be analyzed using single-variable and multi-variable analysis.

Management information
Registered date
2009 Year 09 Month 27 Day
Last modified on
2010 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003000

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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