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

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 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


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

Value
https://center6.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