UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Accuracy of Endocytoscopic Diagnosis of Colorectal Lesions Comparing with Biopsy: A Prospective Randomized Controlled Trial
Title of the study (Brief title)	The Accuracy of Endocytoscopic Diagnosis of Colorectal Lesions Comparing with Biopsy: A Prospective Randomized Controlled Trial (EB-Trial)
Region	Japan

Condition
Condition	Colorectal polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this prospective randomized controlled trial is to evaluate the usefulness of optical biopsy of colorectal lesions with Endocytoscopy(EC) comparing with biopsy(Bx).
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The accuracy of differencial diagnosis between neoplastic and non-neoplastic
Key secondary outcomes	The accuracy of differential diagnosis between low grade adenoma and high grade adenoma, Time of examination, Complication, Cost The accuracy of diagnose massively invasive submucosal cancers with EC The diagnostic accuracies of NBI and pit pattren in the colorectum compared to Bx. The diagnostic accuracy of EC compared to NBI and pit pattern

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Ultra magnification endoscopy; Endocytoscopy(CF-Y0001and CF-Y0002, Olympus, Tokyo, Japan)
Interventions/Control_2	Biopsy
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with colorectal polyps (>5mm) who have agreement to our study and undergo colonoscopy with Endocytoscope
Key exclusion criteria	Patients who take antiplatelets or anticoagulants Patients with inflammatory bowel disease
Target sample size	200

Research contact person
Name of lead principal investigator	Yuichi Mori
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Address	35-1, Chigasaki-tyuo, Tuzuki-ku, Yokohama-shi, Japan
TEL	045-949-7693
Email

Public contact
Name of contact person	Yuichi Mori
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Address	35-1, Chigasaki-tyuo, Tuzuki-ku, Yokohama-shi, Japan
TEL	045-949-7693
Homepage URL
Email	ibusiginjp@hotmail.com

Sponsor
Institute	Digestive Disease Center , Showa University Northern Yokohama 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	昭和大学横浜市北部病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2010 Year 07 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 06 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2011 Year 04 Month 01 Day
Date of closure to data entry	2011 Year 06 Month 01 Day
Date trial data considered complete	2011 Year 06 Month 01 Day
Date analysis concluded	2011 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Endocytoscopy is noninferior to standard biopsy for the discrimination of neoplastic lesions.
Other related information	Published in "Endoscopy". Mori Y, Kudo S, Ikehara N.et al. Comprehensive diagnostic ability of endocytoscopy compared with biopsy for colorectal neoplasms: a prospective randomized noninferiority trial. Endoscopy 2013; 45:98-105

Management information
Registered date	2010 Year 07 Month 17 Day
Last modified on	2019 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004715