UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010424 |
|---|---|
| Receipt number | R000012192 |
| Scientific Title | Timing of endoscopic biliary drainage in patients with moderate acute cholangitis: A prospective randomized controlled trial (TEMAC trial) |
| Date of disclosure of the study information | 2013/04/05 |
| Last modified on | 2015/10/25 13:18:11 |
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Basic information
Public title
Timing of endoscopic biliary drainage in patients with moderate acute cholangitis: A prospective randomized controlled trial (TEMAC trial)
Acronym
Timing of endoscopic biliary drainage in patients with moderate acute cholangitis; A prospective randomized controlled trial (TEMAC trial)
Scientific Title
Timing of endoscopic biliary drainage in patients with moderate acute cholangitis: A prospective randomized controlled trial (TEMAC trial)
Scientific Title:Acronym
Timing of endoscopic biliary drainage in patients with moderate acute cholangitis; A prospective randomized controlled trial (TEMAC trial)
Region
| Japan |
Condition
Condition
moderate acute cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the rate of developing severe acute cholangitis during clinical course between two groups (<24hrs, >=24hrs)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of developing severe cholangitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
endoscopic biliary drainage within 24hrs
Interventions/Control_2
endoscopic biliary drainage after 24hrs
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
moderate acute cholangitis according to TG13
age over than 20yrs
written IC
Key exclusion criteria
coexistent gall stone pancreatitis
age under than 20 yrs
pregnancy
reconstructed stomach other than B1
bleeding tendency
unable to obtain written IC
Target sample size
196
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TESSHIN BAN |
Organization
Nagoya daini red cross hospital
Division name
Gastroenterology
Zip code
Address
2-9 Myokencho, showa-ku, Nagoya, Japan
TEL
052-832-1121
venzo@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TESSHIN BAN |
Organization
Nagoya daini red cross hospital
Division name
Gastroenterology
Zip code
Address
2-9 Myokencho, showa-ku, Nagoya, Japan
TEL
052-832-1121
Homepage URL
venzo@nagoya2.jrc.or.jp
Sponsor or person
Institute
Nagoya daini red cross hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 04 | Day |
Last modified on
| 2015 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012192
