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

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 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


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

Value
https://center6.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