UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnostic accuracy of Sessile Serrated Adenoma/Polyps(SSA/P) on magnifying Narrow Band Imaging(NBI) and biopsy diagnosis: A prospective controlled study of diagnostic accuracy
Title of the study (Brief title)	Diagnostic accuracy of SSA/P on Magnifying NBI and biopsy diagnosis: A prospective controlled study of diagnostic accuracy
Region	Japan

Condition
Condition	Sessile serrated adenoma/polyp(SSA/P)
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study compared the accuracy of endoscopic diagnosis using magnifying NBI versus biopsy diagnosis of SSA/P.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy of endoscopic diagnosis using magnifying NBI and biopsy diagnosis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	undergo biopsy from specimen which suspected SSA/P by endoscopic diagnosis.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Colorectal SSA/P 6< in diameter.
Key exclusion criteria	1) after right hemicolectomy 2) inflammatory bowel disease 3) patients whom a researcher judged to be inappropriate as a subject
Target sample size	90

Research contact person
Name of lead principal investigator	Yamashina Takeshi
Organization	Osaka Red Cross Hospital
Division name	Gastroenterology and Hepatology
Address	5-30 Fudegasaki-cho, Tennojikui-ku, Osaka, Japan
TEL	06-6774-5111
Email	t.yamashina@osaka-med.jrc.or.jp

Public contact
Name of contact person	Yamashina Takeshi
Organization	Osaka Red Cross Hospital
Division name	Gastroenterology and Hepatology
Address	5-30 Fudegasaki-cho, Tennojikui-ku, Osaka, Japan
TEL	06-6774-5111
Homepage URL
Email	t.yamashina@osaka-med.jrc.or.jp

Sponsor
Institute	Gastroenterology and Hepatology, Osaka Red Cross Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 27 Day
Anticipated trial start date	2015 Year 08 Month 27 Day
Last follow-up date
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	2015 Year 08 Month 27 Day
Last modified on	2018 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021787