The significance of new lightning systems, Narrow band imaging and Autofluorescence imaging, in the diagnosis of gastrointestinal tumors

UMIN ID: UMIN000002019

Registered date:13/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gastrointestinal tumors
• Date of first enrollment: 2007/04/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

• Primary Outcome: 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
• Secondary Outcome: 1) Interobserver consistency in the assessment of AFI 2) Interobserver consistency in the assessment of NBI 3) Histological factors affecting AFI and NBI

Key inclusion & exclusion criteria

• Age minimum: 12years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University
• Source(s) of Monetary Support: none