UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Endoscopy with linked color imaging (LCI) for superficial nonampullary duodenal epithelial tumor (SNADET)
Acronym	LCI for SNADET
Scientific Title	Efficacy of Endoscopy with linked color imaging (LCI) for superficial nonampullary duodenal epithelial tumor (SNADET)
Scientific Title:Acronym	LCI for SNADET
Region	Japan

Condition
Condition	Sporadic nonampullary duodenal adenoma/carcinoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the efficacy of endoscopy with LCI for SNADET
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The Visibility score of endoscopy with LCI for SNADET, and the relationship between this and the score of endoscopy with WLI, BLI, and BLI bright
Key secondary outcomes	The relationship between the Visibility score and patients characteristics (e.g. age, gender, and comorbidity), lesions characteristics (e.g. location, diameter, macroscopic appearance, and pathological findings) and objective assessment using graphics software

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	Patients with sporadic SNADET
Key exclusion criteria	Patients with polyposis syndrome such as FAP, or evaluated incompetent by doctors in attendance
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Arai
Organization	Chiba University Hospital
Division name	Gastroenterology
Zip code	260-8670
Address	Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL	+81-43-226-2083
Email	araim-cib@umin.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Maruoka
Organization	Chiba University Hospital
Division name	Gastroenterology
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL	+81-43-226-2083
Homepage URL
Email	maruoka-cib@umin.ac.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
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	Graduate School of Medicine, Chiba University
Address	1-8-1, Inohana, Chuo-Ku, Chiba, Japan
Tel	0432227171
Email	maruoka-cib@umin.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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 25 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691495/
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691495/
Number of participants that the trial has enrolled	44
Results	For SNADETs of 44 patients, the visibility scores of LCI (3.53+-0.59) were significantly higher than those of WLI and BLI-b (2.66+-0.79 and 3.41+-0.64, respectively). The color differences between SNADETs and the adjacent normal duodenal mucosa in LCI mode (19.09+-8.33) were significantly higher than those in WLI and BLI-b modes (8.67+-4.81 and 12.92+-7.95, respectively).
Results date posted	2022 Year 01 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	In total, 44 patients and 44 lesions were evaluated. The mean age was 66.2+-9.5. Male were 32 and female were 12. The mean tumor size was 9.7+-5.9mm.
Participant flow	Between September 2017 and June 2019, consecutive patients diagnosed with SNADETs were enrolled in this study.
Adverse events	None
Outcome measures	Visibility score Color difference
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 25 Day
Date of IRB	2017 Year 12 Month 19 Day
Anticipated trial start date	2017 Year 12 Month 19 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Efficacy of endoscopy with LCI for SNADET will be analyzed.

Management information
Registered date	2017 Year 08 Month 25 Day
Last modified on	2022 Year 01 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033008