UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017618
Receipt number R000020418
Scientific Title Investigation of the duodenal lesions using endocytoscopy system
Date of disclosure of the study information 2015/05/19
Last modified on 2018/10/11 15:17:57

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Basic information

Public title

Investigation of the duodenal lesions using endocytoscopy system

Acronym

Endocutoscopy system for duodenal lesions

Scientific Title

Investigation of the duodenal lesions using endocytoscopy system

Scientific Title:Acronym

Endocutoscopy system for duodenal lesions

Region

Japan


Condition

Condition

duodenal lesions

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We clarify the features of the surface cell morphology of both malignant and benign lesions of the duodenum using endocytoscopy system(GIF-Y0002).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Accurate diagnosis rate concerning to the benign or malignant of the endocytoscopic pictures

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine Device,equipment

Interventions/Control_1

We spray methylene blue or toluidine blue inside the duodenum as vital staining.We contact the tip of the endocytoscope to the target mucosa.We confirm the histological diagnosis of the target lesion using biopsy specimen.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who agree this study and have duodenal lesions.

Key exclusion criteria

Patients who have the history of side effect using methylene blue or toluidine blue.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Youichi Kumagai

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Digestive tract and General Surgery

Zip code


Address

1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, Japan

TEL

049-228-3619

Email

kuma7srg1@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Youichi Kumagai

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Digestive tract and General Surgery

Zip code


Address

1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, Japan

TEL

049-228-3619

Homepage URL


Email

kuma7srg1@gmail.com


Sponsor or person

Institute

Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical Center, Saitama Medical University

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

埼玉医科大学総合医療センター(埼玉県)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 19 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 10 Month 03 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 03 Day

Last follow-up date

2018 Year 10 Month 11 Day

Date of closure to data entry

2018 Year 10 Month 11 Day

Date trial data considered complete

2018 Year 10 Month 11 Day

Date analysis concluded

2018 Year 10 Month 11 Day


Other

Other related information



Management information

Registered date

2015 Year 05 Month 19 Day

Last modified on

2018 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020418


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name