UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002019
Receipt number 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 16:12:12

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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