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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033646
Receipt No. R000038364
Scientific Title USEFULNESS OF IMAGE ENHANCED ENDOSCOPY FOR RECOGNITION OF EARLY GASTRIC CANCER AND ADENOMA
Date of disclosure of the study information 2018/08/06
Last modified on 2018/12/30

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Basic information
Public title USEFULNESS OF IMAGE ENHANCED ENDOSCOPY FOR RECOGNITION OF EARLY GASTRIC CANCER AND ADENOMA
Acronym COMPARING IEE FOR RECOGNITION OF EARLY GASTRIC TUMOR
Scientific Title USEFULNESS OF IMAGE ENHANCED ENDOSCOPY FOR RECOGNITION OF EARLY GASTRIC CANCER AND ADENOMA
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Nobuaki Yagi
Organization Asahi University Hospital
Division name Department of Gastroenterology
Zip code
Address 3-23, Hashimoto-cho, Gifu
TEL +81-58-253-8001
Email nyagi@koto.kpu-m.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takeshi Yasuda
Organization Asahi University Hospital
Division name Department of Gastroenterology
Zip code
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)

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 朝日大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 06 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
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.
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
2018 Year 07 Month 06 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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