UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003923 |
|---|---|
| Receipt number | 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 20:14:21 |
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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
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
ibusiginjp@hotmail.com
Sponsor or person
Institute
Digestive Disease Center , Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004715
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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