UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003126
Receipt number R000003791
Scientific Title A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor
Date of disclosure of the study information 2010/02/01
Last modified on 2013/02/06 15:48:40

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor

Acronym

A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor

Scientific Title

A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor

Scientific Title:Acronym

A study about the validity and safety of sphincter of Oddi manometory using the wire-type coronary arteries pressure monitor

Region

Japan


Condition

Condition

The pancreatic and biliary diseases including the dysfunction of sphincter of Oddi

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Validity and safety of measuring the pressure of sphincter of Oddi

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The pressure of sphincter of Oddi

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Measuring the pressure of sphincter of Oddi

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

The patients who have the pancreatic and biliary diseases including Sphincter of Oddi dysfunction

Key exclusion criteria

1)Patients without written informed consent
2)Patients with severe concurrent diseases

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromu Kutsumi

Organization

Kobe University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL

078-382-6980

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kobe University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Gastroenterology, Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology, Kobe University Graduate School of Medicine

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

2010 Year 02 Month 01 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

Completed

Date of protocol fixation

2009 Year 11 Month 25 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

2012 Year 03 Month 01 Day

Date trial data considered complete

2012 Year 03 Month 01 Day

Date analysis concluded

2012 Year 03 Month 10 Day


Other

Other related information



Management information

Registered date

2010 Year 02 Month 01 Day

Last modified on

2013 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003791


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name