UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002552 |
|---|---|
| Receipt number | 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 21:36:24 |
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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
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/
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
