UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021306
Receipt number R000024569
Scientific Title The usefulness of Dual Red Imaging function in diagnosing and treating esophageal varices (comparison with endoscopic ultrasonography)
Date of disclosure of the study information 2016/03/03
Last modified on 2019/09/06 16:35:20

* 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

The usefulness of Dual Red Imaging function in diagnosing and treating esophageal varices
(comparison with endoscopic ultrasonography)

Acronym

The usefulness of Dual Red Imaging function

Scientific Title

The usefulness of Dual Red Imaging function in diagnosing and treating esophageal varices
(comparison with endoscopic ultrasonography)

Scientific Title:Acronym

The usefulness of Dual Red Imaging function

Region

Japan


Condition

Condition

Esophageal varices

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The investigation of the changing degree of visibility about esophageal varices with DRI

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The raising rate of visibility of esophageal varices by DRI

Key secondary outcomes

Relation between the degree of visibility change and endoscopic ultrasound image


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Observaion of esophageal varices using image enhanced endoscope with Dual Red Imaging function

Observation using white light as control

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1. WBC > 2000
2. PLT > 20000
3. T-bil < 5.0
4. cases that do not take a Anticoagulant drug or antiplatelet drug or thrombolytic drug

Key exclusion criteria

1. Cases with serever renal or heart disease
2. Pregnancy case

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Furuichi

Organization

Tokyo Medical University

Division name

Gastroenterology and Hepatology

Zip code

1600023

Address

6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan

TEL

0333426111

Email

furuichi@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Yoshihiro
Middle name
Last name Furuichi

Organization

Tokyo Medical University

Division name

Gastroenterology and Hepatology

Zip code

1600023

Address

6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan

TEL

0333426111

Homepage URL


Email

furuichi@tokyo-med.ac.jp


Sponsor or person

Institute

Tokyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical University

Address

6-7-1 Nishi-shinjuku shinjuku-ku

Tel

0333426111

Email

furuichi@tokyo-med.ac.jp


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

2016 Year 03 Month 03 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

2014 Year 11 Month 02 Day

Date of IRB

2014 Year 10 Month 06 Day

Anticipated trial start date

2016 Year 03 Month 03 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 03 Day

Last modified on

2019 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024569


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name