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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016367
Receipt No. 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

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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
Email 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
Email yasuharumaeda610@hotmail.com

Sponsor
Institute Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019007

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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