UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	USEFULNESS OF IMAGE ENHANCED ENDOSCOPY FOR RECOGNITION OF EARLY GASTRIC CANCER AND ADENOMA
Title of the study (Brief title)	COMPARING IEE FOR RECOGNITION OF EARLY GASTRIC TUMOR
Region	Japan

Condition
Condition	Early gastric cancer and gastric adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to evaluate the usefulness of LCI for recognition of early gastric cancer and adenoma compared to conventional white light imaging mode (WLI), WLI with indigo carmine contrast (IC) and blue laser imaging bright mode (BLI-brt).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recognition score that performed by three endoscopists and the L*a*b* color space-based color difference scores between inside and outside of the lesion.
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who were examined by all four imaging (WLI, IC, BLI-brt and LCI) before endoscopic submucosal dissection at Asahi University Hospital.
Key exclusion criteria	Cases that principal investigator has determined to be inappropriate for this study.
Target sample size	90

Research contact person
Name of lead principal investigator	Nobuaki Yagi
Organization	Asahi University Hospital
Division name	Department of Gastroenterology
Address	3-23, Hashimoto-cho, Gifu
TEL	+81-58-253-8001
Email	nyagi@koto.kpu-m.ac.jp

Public contact
Name of contact person	Takeshi Yasuda
Organization	Asahi University Hospital
Division name	Department of Gastroenterology
Address	3-23, Hashimoto-cho, Gifu
TEL	+81-58-253-8001
Homepage URL
Email	t-yasuda@koto.kpu-m.ac.jp

Sponsor
Institute	Asahi University
Institute
Department

Funding Source
Organization	Asahi University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	朝日大学病院

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 06 Day
Anticipated trial start date	2018 Year 08 Month 06 Day
Last follow-up date	2018 Year 12 Month 28 Day
Date of closure to data entry	2018 Year 12 Month 30 Day
Date trial data considered complete	2018 Year 12 Month 30 Day
Date analysis concluded	2019 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The overall mean RS of LCI was significantly higher than that of WLI,IC,BLI-brt. The overall mean CDS of LCI was significantly higher than that of WLI,IC,BLI-brt. Subgroup analysis based on tumor type revealed that both RS and CDS of LCI for type 0-IIb or 0-IIc lesions (63 lesions) were significantly higher (p<0.01) than those of WLI, IC,BLI-brt. On the other hand, regarding type 0-IIa lesions or adenomas the overall mean RS of LCI, as well as IC was significantly higher (p<0.01) than that of WLI,BLI-brt. The overall mean CDS of LCI, as well as IC and BLI-brt were significantly higher (p<0.01) than those of WLI.
Other related information	To evaluate the usefulness of LCI for recognition of early gastric cancer and adenoma compared to conventional WLI,IC and BLI-brt at Asahi University Hospital. Both subjective and objective evaluation methods were adopted to quantify the recognition of early gastric cancer and adenoma.

Management information
Registered date	2018 Year 08 Month 06 Day
Last modified on	2018 Year 12 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038364