UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044149
Receipt number R000050413
Scientific Title Usefulness of gastritis evaluation by image-enhanced endoscopy: Randomized controlled trial
Date of disclosure of the study information 2021/05/09
Last modified on 2021/05/09 12:46:00

* 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

Usefulness of gastritis evaluation by image-enhanced endoscopy: Randomized controlled trial

Acronym

Usefulness of gastritis evaluation by image-enhanced endoscopy: Randomized controlled trial

Scientific Title

Usefulness of gastritis evaluation by image-enhanced endoscopy: Randomized controlled trial

Scientific Title:Acronym

Usefulness of gastritis evaluation by image-enhanced endoscopy: Randomized controlled trial

Region

Japan


Condition

Condition

Patients receiving upper gastrointestinal endoscopy

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

(1) To clarify appropriate observation method for evaluation of findings including gastric mucosal atrophy and intestinal metaplasia by image-enhanced endoscope
(2) To clarify efficacy of the evaluation of gastric lesions between image-enhanced endoscopes and white-light endoscopy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of white light and image-enhanced endoscopy in diagnostic ability by gastritis findings

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Endoscopy
1. White light-narrow band imaging

Interventions/Control_2

2. White light-TXI

Interventions/Control_3

3. narrow band imaging-White light

Interventions/Control_4

4. TXI-white light

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Those who are 20 years of age or older and have consented to participate in this study by signing a consent form from the person himself / herself.

Key exclusion criteria

1. Those who did not agree to participate in this study
2. Those with serious complications (heart failure, liver failure, respiratory failure)
3. Pregnant or lactating
4. Others who are judged to be inappropriate for participating in this study

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Mitsushige
Middle name
Last name Sugimoto

Organization

Tokyo Medical University Hospital

Division name

Department of Gastroenterological Endoscopy

Zip code

160-0023

Address

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

TEL

03-3342-6111

Email

sugimo@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Mitsushige
Middle name
Last name Sugimoto

Organization

Tokyo Medical University Hospital

Division name

Department of Gastroenterological Endoscopy

Zip code

160-0023

Address

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

TEL

03-3342-6111

Homepage URL


Email

sugimo@tokyo-med.ac.jp


Sponsor or person

Institute

Tokyo Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical University Hospital

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

Insitutional Review Board, Tokyo MEdical University

Address

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

Tel

03-3342-6111

Email

IRB@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

2021 Year 05 Month 09 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

2021 Year 02 Month 02 Day

Date of IRB

2021 Year 02 Month 17 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2022 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

2021 Year 05 Month 09 Day

Last modified on

2021 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050413


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name