UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of Image-Enhanced Endoscopy for diagnosis of colorectal neoplasms
Title of the study (Brief title)	Usefulness of Image-Enhanced Endoscopy for diagnosis of colorectal neoplasms
Region	Japan

Condition
Condition	colorectal neoplasms
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Usefulness of IEE for colorectal neoplasms
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Usefulness of IEE for colorectal neoplasms
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1,Patients that Endoscopic biopsy or resection or surgical resection of colorectal neoplasms is planned 2,20 years old or older 3,Patients who provided written informed consent
Key exclusion criteria	1,Patients who judged that we are inappropriate 2,Patients without the ability for self-decision 3,Colorectal neoplasms with chemotherapy or radiation therapy
Target sample size	210

Research contact person
Name of lead principal investigator	Masanao Nakamura
Organization	Nagoya University Hospital
Division name	Gastroenterology and Hepatology
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2172
Email	makamura@med.nagoya-u.ac.jp

Public contact
Name of contact person	Arihiro Nakano
Organization	Nagoya University Hospital
Division name	Gastroenterology and Hepatology
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2172
Homepage URL
Email	arihiro-31@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Nagoya University Hospital
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Nagoya University Hospital
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

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 02 Month 27 Day
Last follow-up date	2017 Year 12 Month 31 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	Comparison of IEE(BLI or NBI) versus white lignt and chromoendoscopy for detection rate and diagnosis of colorectal neoplasms

Management information
Registered date	2013 Year 11 Month 19 Day
Last modified on	2016 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014384