UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033646 |
|---|---|
| Receipt number | 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 12:15:12 |
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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
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
nyagi@koto.kpu-m.ac.jp
Public contact
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
t-yasuda@koto.kpu-m.ac.jp
Sponsor or person
Institute
Asahi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038364
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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