UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009838
Receipt number R000011532
Scientific Title Prospective study of efficacy of magnifying endoscopy with narrow band imaging in the differential diagnosis of sporadic nonampullary duodenal low-grade dysplasia or high-grade dysplasia/intramucosal carcinoma
Date of disclosure of the study information 2013/01/22
Last modified on 2020/01/28 21:26:43

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Basic information

Public title

Prospective study of efficacy of magnifying endoscopy with narrow band imaging in the differential diagnosis of sporadic nonampullary duodenal low-grade dysplasia or high-grade dysplasia/intramucosal carcinoma

Acronym

Magnifying endoscopy with narrow band imaging in the differential diagnosis of duodenal adenomatous lesion

Scientific Title

Prospective study of efficacy of magnifying endoscopy with narrow band imaging in the differential diagnosis of sporadic nonampullary duodenal low-grade dysplasia or high-grade dysplasia/intramucosal carcinoma

Scientific Title:Acronym

Magnifying endoscopy with narrow band imaging in the differential diagnosis of duodenal adenomatous lesion

Region

Japan


Condition

Condition

sporadic nonampullary duodenal adenomatous lesion

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To reveal the efficacy of magnifying endoscopy with narrow band imaging in the differential diagnosis of duodenal adenomatous lesion

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The findings of lesions using magnifying endoscopy with narrow band imaging

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with nonampullary duodenal adenomatous lesion

Key exclusion criteria

Patients with polyposis syndrome or evaluated incompetent by doctors in attendance

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Arai

Organization

Chiba University Hospital

Division name

Gastroenterology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba City

TEL

043-226-2083

Email

araim-cib@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Arai

Organization

Chiba University Hospital

Division name

Gastroenterology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN

TEL

043-226-2083

Homepage URL


Email

araim-cib@umin.ac.jp


Sponsor or person

Institute

Chiba Univeristy

Institute

Department

Personal name



Funding Source

Organization

Chiba Univeristy

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

2013 Year 01 Month 22 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

No longer recruiting

Date of protocol fixation

2011 Year 01 Month 01 Day

Date of IRB

2011 Year 01 Month 01 Day

Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date

2020 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We perform a prospective study for magnifying endoscopy with narrow band imaging in the differential diagnosis of sporadic nonampullary duodenal low-grade dysplasia or high-grade dysplasia/intramucosal carcinoma


Management information

Registered date

2013 Year 01 Month 22 Day

Last modified on

2020 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=R000011532


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name