UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031569 |
|---|---|
| Receipt number | R000036044 |
| Scientific Title | A study on the usefulness of blood ATP concentration for the severity assessment of acute cholangitis and cholecystitis. |
| Date of disclosure of the study information | 2018/03/05 |
| Last modified on | 2018/03/04 21:38:21 |
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Basic information
Public title
A study on the usefulness of blood ATP concentration for the severity assessment of acute cholangitis and cholecystitis.
Acronym
The correlation between acute cholangio-cholecystitis and blood ATP concentration.
Scientific Title
A study on the usefulness of blood ATP concentration for the severity assessment of acute cholangitis and cholecystitis.
Scientific Title:Acronym
The correlation between acute cholangio-cholecystitis and blood ATP concentration.
Region
| Japan |
Condition
Condition
acute cholangio-cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is aimed to evaluate the efficacy of assessment severity of cholangio-cholecystitis by measuring blood ATP concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentration of blood ATP before and after the treatment of cholangio-cholecystitis.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patient of cholangitis or cholecystitis
2) over 20 year olds
3) Informed consent about this research has been obtained with participants in writing form.
Key exclusion criteria
1) the research director cannot get informed consent from participant or their family.
2) under 20 year olds
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Mishiro |
Organization
Shimane university school of medicine
Division name
Division of gastroenterology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853-20-2190
tmishiro@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Mishiro |
Organization
Shimane university school of medicine
Division name
Division of gastroenterology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853-20-2190
Homepage URL
tmishiro@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university school of medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2018 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We measure the concentration of blood adenosine tri-phosphate with 18 participants by the luminometer, and determine the need to perform emergency biliary drainage of acute cholangitis or cholecystitis .
Management information
Registered date
| 2018 | Year | 03 | Month | 04 | Day |
Last modified on
| 2018 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036044
