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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002019
Receipt No. R000002463
Scientific Title The significance of new lightning systems, Narrow band imaging and Autofluorescence imaging, in the diagnosis of gastrointestinal tumors
Date of disclosure of the study information 2009/07/13
Last modified on 2018/09/13

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Basic information
Public title The significance of new lightning systems, Narrow band imaging and Autofluorescence imaging, in the diagnosis of gastrointestinal tumors
Acronym The significant of NBI and AFI in diagnosing gastrointestinal tumors
Scientific Title The significance of new lightning systems, Narrow band imaging and Autofluorescence imaging, in the diagnosis of gastrointestinal tumors
Scientific Title:Acronym The significant of NBI and AFI in diagnosing gastrointestinal tumors
Region
Japan

Condition
Condition Gastrointestinal tumors
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Laboratory medicine
Operative medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To elucidate the efficacy of Narrow band imaging and Autofluorescence imaging in diagnosing gastrointestinal tumors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1) The relationship between AFI and histological or genetic features of gastrointestinal tumors
2) The relationship between NBI and histological or genetic features of gastrointestinal tumors
Key secondary outcomes 1) Interobserver consistency in the assessment of AFI
2) Interobserver consistency in the assessment of NBI
3) Histological factors affecting AFI and NBI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Gene Device,equipment
Interventions/Control_1 Endoscopy with special lightning systems.
1)Instruments: CV-260S, CLV-260SL, CF-FH260AZI (Olympus Corp. Japan)
2)Features: An AFI and NBI image are easily obtained at any time by manipulating a button on the control portion. The strength of fluorescence emitted from intestinal tissues of AFI images are quantified with image-analytical software. This quantification is performed by an endoscopist who do not participate in assessing the visual classification and is aware of no endoscopic or histological information.
3)Endoscopic procedure
AFI images obtained from the lesions are evaluated as predominant color intensities depending on the autofluorescence reflection. NBI images obtained from the lesions are evaluated as the density and irregularity of tumor vessels. AFI and NBI images are visually evaluated by three endoscopists during the procedure without any histological information. The dysplastic grade is diagnosed by a pathologist with no clinical and endoscopic information according to the Vienna classification. In addition, the quatification od AFI images is calculated right after the endoscopic examination by endoscopists who do not participate in assessing the visual classification and have no knowledge of the endoscopic and histological information.
Interventions/Control_2 Conventional endoscopy.
1)Instruments: CV-260S, CLV-260SL, CF-FH260AZI (Olympus Corp. Japan)
2)Features: An AFI and NBI image are easily obtained at any time by manipulating a button on the control portion. The strength of fluorescence emitted from intestinal tissues of AFI images are quantified with image-analytical software. This quantification is performed by an endoscopist who do not participate in assessing the visual classification and is aware of no endoscopic or histological information.
3)Endoscopic procedure
AFI images obtained from the lesions are evaluated as predominant color intensities depending on the autofluorescence reflection. NBI images obtained from the lesions are evaluated as the density and irregularity of tumor vessels. AFI and NBI images are visually evaluated by three endoscopists during the procedure without any histological information. The dysplastic grade is diagnosed by a pathologist with no clinical and endoscopic information according to the Vienna classification. In addition, the quatification od AFI images is calculated right after the endoscopic examination by endoscopists who do not participate in assessing the visual classification and have no knowledge of the endoscopic and histological information.
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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who need to undergo endoscopy by any reasons
Key exclusion criteria Patients with severe cardiac disease
Patients with severe renal dysfunction
Patients with severe liver dysfunction
Patients with severe infectious disease
Patients with severe dehydration or malnutrition
Patients with abnormal blood coagulation
Patients with severe dilatation or perforation in the stomach or intestine
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikihiro Fujiya
Organization Asahikawa Medical University
Division name Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
Address 2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan
TEL 81-166-68-2462
Email fjym@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikihiro Fujiya
Organization Asahikawa Medical University
Division name Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
Address 2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL 81-166-68-2462
Homepage URL
Email fjym@asahikawa-med.ac.jp

Sponsor
Institute Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 旭川医科大学病院(北海道)
Asahikaw Medical University Hospital (Hokkaido)

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 13 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 Completed
Date of protocol fixation
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2017 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 30 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002463

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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