UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014013
Receipt number R000016321
Scientific Title Improvement in the Detectability of Colorectal Polyps using appropriate setting of narrow Band Imaging and white light
Date of disclosure of the study information 2014/05/20
Last modified on 2021/09/26 22:27:24

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Basic information

Public title

Improvement in the Detectability of Colorectal Polyps using appropriate setting of narrow Band Imaging and white light

Acronym

Detectability of Colorectal Polyps using NBI and WL

Scientific Title

Improvement in the Detectability of Colorectal Polyps using appropriate setting of narrow Band Imaging and white light

Scientific Title:Acronym

Detectability of Colorectal Polyps using NBI and WL

Region

Japan


Condition

Condition

colorectal polyps

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether NBI and white light (WL) can improve the detectability of colorectal polyps using endoscopic figures and videos.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The poloyp visibility scores with various setting of NBI and WL were analyzed, regarding to the clinical characteristics.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Colorectal polyps less than 20mm in size, whose movies using NBI and WL were recorded

Key exclusion criteria

Polyps whose movies of NBI and Wl were not recorded in similar situation.
Polyps whose histopathoological examination was not performed.
Inflammatory polyp

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naohisa Yoshida

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

8175251555519

Email

naohisa@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naohisa Yoshida

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

81752515519

Homepage URL


Email

naohisa@koto.kpu-m.ac.jp


Sponsor or person

Institute

Naohisa Yoshida

Institute

Department

Personal name



Funding Source

Organization

Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University 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

2014 Year 05 Month 20 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

2013 Year 03 Month 01 Day

Date of IRB

2013 Year 03 Month 01 Day

Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2018 Year 04 Month 01 Day

Date of closure to data entry

2018 Year 04 Month 01 Day

Date trial data considered complete

2018 Year 04 Month 01 Day

Date analysis concluded

2018 Year 04 Month 01 Day


Other

Other related information

With random sampling, endoscopic figures and video taken by various setting with NBI and WL are analysed for the improvement of colorectal polyps.


Management information

Registered date

2014 Year 05 Month 20 Day

Last modified on

2021 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016321


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name