UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043573
Receipt number R000049719
Scientific Title Visibility of duodenal epithelial tumors by Texture and Color Enhancement Imaging and Narrow band imaging in underwater conditions
Date of disclosure of the study information 2021/04/01
Last modified on 2022/07/23 10:26:18

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Basic information

Public title

Visibility of duodenal epithelial tumors by Texture and Color Enhancement Imaging and Narrow band imaging in underwater conditions

Acronym

Visibility of duodenal epithelial tumors by TXI and NBI in underwater conditions

Scientific Title

Visibility of duodenal epithelial tumors by Texture and Color Enhancement Imaging and Narrow band imaging in underwater conditions

Scientific Title:Acronym

Visibility of duodenal epithelial tumors by TXI and NBI in underwater conditions

Region

Japan


Condition

Condition

duodenal epithelial tumors

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Visibility for duodenal epithelial tumors by TXI and NBI in underwater conditions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visibility for duodenal epithelial tumors in underwater conditions

Key secondary outcomes

color difference between tumors and duodenal mucosa


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


Not applicable

Gender

Male and Female

Key inclusion criteria

The case with duodenal epithelial tumors who will undergo endoscopic examination at Kyoto Prefectural University of Medicine and relative institutions.

Key exclusion criteria

Cases that principal investigator has determined to be inappropriate for this study.
Cases who are less than 20 years old

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Dohi

Organization

Kyoto Prefectural University of Medicine

Division name

Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kaji-cho, Kamijyo-ku, Kyoto, Japan

TEL

075-251-5519

Email

osamu-d@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Hayato
Middle name
Last name Fukui

Organization

Kyoto Prefectural University of Medicine

Division name

Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kaji-cho, Kamijyo-ku, Kyoto, Japan

TEL

075-251-5519

Homepage URL


Email

h-fukui@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

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

Kyoto Prefectural University of Medicine

Address

465 Kaji-cho, Kamijyo-ku, Kyoto, Japan

Tel

075-251-5337

Email

rinri@koto.kpu-m.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 04 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

Enrolling by invitation

Date of protocol fixation

2021 Year 03 Month 09 Day

Date of IRB

2021 Year 05 Month 07 Day

Anticipated trial start date

2022 Year 07 Month 22 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The aim of this study is to evaluate the visibility and color difference of images using TXI and NBI with WLI for duodenal epithelial tumors.


Management information

Registered date

2021 Year 03 Month 10 Day

Last modified on

2022 Year 07 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049719


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name