UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The significance of new lightning systems, Narrow band imaging and Autofluorescence imaging, in the diagnosis of gastrointestinal tumors
Title of the study (Brief title)	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	Mikihiro Fujiya
Organization	Asahikawa Medical University
Division name	Division of Gastroenterology and Hematology/Oncology, Department of Medicine
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	Mikihiro Fujiya
Organization	Asahikawa Medical University
Division name	Division of Gastroenterology and Hematology/Oncology, Department of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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