UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016367 |
|---|---|
| Receipt number | R000019007 |
| Scientific Title | The management of colorectal diminutive adenomatous polyps using pit pattern classification with magnifying chromoendoscopy |
| Date of disclosure of the study information | 2015/01/28 |
| Last modified on | 2015/01/28 19:29:49 |
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Basic information
Public title
The management of colorectal diminutive adenomatous polyps
using pit pattern classification with magnifying chromoendoscopy
Acronym
The management of DAPs using pit
Scientific Title
The management of colorectal diminutive adenomatous polyps
using pit pattern classification with magnifying chromoendoscopy
Scientific Title:Acronym
The management of DAPs using pit
Region
| Japan |
Condition
Condition
Colorectal Neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is investigating the feasibility of the strategy of colorectal DAPs using pit pattern classification.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary goal is to address the hypothesis that after two complete colonoscopies with the removal of all polyps detected, the incidence of clinically significant lesions would not be different between patients undergoing two further follow-up examinations and those undergoing just one. Clinically significant lesions are defined as index lesions (IL): if they are larger than 10mm; if they have high-grade dysplasia; or if they are invasive.
Key secondary outcomes
The secondary endpoint: Colorectal cancer reduction rate cause of endoscopic polypectomy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
patients whose DAPs with type IIIL PIT were left untreated.
Interventions/Control_2
patients whose all neoplastic polyps including DAPs were resected.
Interventions/Control_3
patients without any adenomatous polyp.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo were referred for initial total colonoscopy with magnifying endoscopy were followed up for more than 3 years.
Key exclusion criteria
Exclusion criteria was patients who had the lesions >5mm in diameter and/or with type IIIs, IV, V PIT left untreated at initial treatment, and those who have a history of familial adenomatous polyposis, Lynch syndrome, Advanced colorectal cancer, Inflammatory bowel disease and operation of colorectum.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yasuharu maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1 Tuzuki, Yokohama, Kanagawa 224-8503, Japan.
TEL
0459497000
yasuharumaeda610@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yasuharu maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1 Tuzuki, Yokohama, Kanagawa 224-8503, Japan.
TEL
0459497000
Homepage URL
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Center, Showa University Northern Yokohama Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2014 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 28 | Day |
Last modified on
| 2015 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019007
