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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031569
Receipt No. 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

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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
Email 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
Email tmishiro@med.shimane-u.ac.jp

Sponsor
Institute Shimane university school of medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036044

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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