UMIN-CTR Clinical Trial

Basic information
Public title	Usability of image-enhanced endoscope system (Lezario: FUJIFILM Corporation) in familial adenomatous polyposis
Acronym	Usability of image-enhanced endoscope system (Lezario: FUJIFILM Corporation) in familial adenomatous polyposis
Scientific Title	Usability of image-enhanced endoscope system (Lezario: FUJIFILM Corporation) in familial adenomatous polyposis
Scientific Title:Acronym	Usability of image-enhanced endoscope system (Lezario: FUJIFILM Corporation) in familial adenomatous polyposis
Region	Japan

Condition
Condition	familial adenomatous polyposis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to collect on the observation ability of neoplastic lesion in fundic gland polyp by the image-enhanced endoscope system (Lezario: FUJIFILM Co) in familial adenomatous polyposis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Characteristics of endoscopic findings compared with conventional white light of linked color imaging and blue laser imaging of neoplastic lesions in fundic gland polyp in familial adenomatous polyposis
Key secondary outcomes	1. Usability of upper gastrointestinal endoscopy in familial adenomatous polyposis (FAP) 2. Usability of colonoscopy in FAP 3. Compare the detection rate of polyps conventional white light of linked color imaging (LCI) and blue laser imaging (BLI) of upper gastrointestinal endoscopy in FAP 4. Compare the detection rate of colon polyps conventional white light of LCI and BLI in FAP 5. Compare the qualititative diagnosis of polyps conventional white light of LCI and BLI of upper gastrointestinal endoscopy in FAP 6. Compare the detection rate of colon polyps conventional white light of LCI and BLI in FAP

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
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. FAP patients who visited Ishikawa Gastrointestinal clinic between approval date and December 31, 2023 2. aged 16 years or older at the time of endoscopy 3. regardless of gender 4. Outpatients only
Key exclusion criteria	1. Evaluated not to be appropriate for inclusion by attending physician 2. When the subject refuses to participate in this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Ishikawa
Organization	Ishikawa gastrointestinal clinic
Division name	Director
Zip code	541-0042
Address	3-2-17, imabashi, chuo-ku, Osaka
TEL	06-6202-6566
Email	cancer@gol.com

Public contact
Name of contact person	1st name Hideki Middle name Last name Ishikawa
Organization	Ishikawa gastrointestinal clinic
Division name	Director
Zip code	541-0042
Address	3-2-17, Imabashi, chuo-ku, Osaka
TEL	0662026566
Homepage URL
Email	cancer@gol.com

Sponsor
Institute	Ishikawa gastrointestinal clinic Director
Institute
Department

Funding Source
Organization	none
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	Kawaramachi-hiroko-ji, Kamigyo-ku, Kyoto 602-8566
Tel	075-251-5111
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	2020 Year 12 Month 22 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	2020 Year 12 Month 19 Day
Date of IRB	2021 Year 09 Month 16 Day
Anticipated trial start date	2021 Year 10 Month 27 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation contents: medical record, endoscope photograph, endoscope moving image

Management information
Registered date	2020 Year 12 Month 22 Day
Last modified on	2021 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048861