UMIN-CTR Clinical Trial

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
Institute	Naohisa Yoshida
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016321