UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003923
Receipt No. R000004715
Scientific Title The Accuracy of Endocytoscopic Diagnosis of Colorectal Lesions Comparing with Biopsy: A Prospective Randomized Controlled Trial
Date of disclosure of the study information 2010/07/20
Last modified on 2019/01/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The Accuracy of Endocytoscopic Diagnosis of Colorectal Lesions Comparing with Biopsy: A Prospective Randomized Controlled Trial
Acronym The Accuracy of Endocytoscopic Diagnosis of Colorectal Lesions Comparing with Biopsy: A Prospective Randomized Controlled Trial (EB-Trial)
Scientific Title The Accuracy of Endocytoscopic Diagnosis of Colorectal Lesions Comparing with Biopsy: A Prospective Randomized Controlled Trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuichi Mori
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1, Chigasaki-tyuo, Tuzuki-ku, Yokohama-shi, Japan
TEL 045-949-7693
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Mori
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Endocytoscopy is noninferior to standard biopsy for the discrimination of neoplastic lesions.
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
2010 Year 07 Month 06 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.