UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023558
Receipt number R000027089
Scientific Title Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study
Date of disclosure of the study information 2016/08/09
Last modified on 2016/08/09 12:30:52

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Basic information

Public title

Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study

Acronym

Evaluation of ulcerative colitis mucosa Linked color imaging LCI

Scientific Title

Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study

Scientific Title:Acronym

Evaluation of ulcerative colitis mucosa Linked color imaging LCI

Region

Japan


Condition

Condition

Ulcerative Colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Efficacy

Basic objectives2

Others

Basic objectives -Others

Diagnosability

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1 Comparison of concordance rate with Mayo endoscopic sub score using WLI and LCI
2 Comparison of concordance rate with Reddening grade using WLI and LCI

Key secondary outcomes

1 Comparison of diagnosis with Mayo endoscopic sub score and biopsy using WLI and LCI
2 Comparison of Reddening grade with Mayo endoscopic sub score and biopsy using WLI and LCI


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

75 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who has inclusion criteria as follows
1 Ulcerative colitis patient
2 Remission and mild activity

Key exclusion criteria

1 carcinoma
2 acute abdomen
3 severe inflammation
4 pregnant woman
5 poor general condition patients who has risk for performing endoscopy such as ileus perforation of intestine pancreatitis respiratory disorder heart failure acquired hemophilia intestinal stricture large ulcer large tumor
6 ongoing anti coagulation therapy or anti platelet therapy
7 intolerance of polyethylene glycol only for transanal approach

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumihito Hirai

Organization

Fukuoka University Chikushi Hospital

Division name

Department of Gastroenterology

Zip code


Address

1-1-1 Zokumyoin Chikushino Fukuoka

TEL

092-921-1011

Email

syokaki@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazutomo Yamasaki

Organization

Fukuoka University Chikushi Hospital

Division name

Department of Gastroenterology

Zip code


Address

1-1-1 Zokumyoin Chikushino Fukuoka

TEL

092-921-1011

Homepage URL


Email

syokaki@fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University Chikushi Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

福岡大学筑紫病院(福岡県)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 09 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

Preinitiation

Date of protocol fixation

2016 Year 03 Month 28 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is prspective and observational study to check evaluation of ulcerative colitis mucosa using Linked color imaging LCI.


Management information

Registered date

2016 Year 08 Month 09 Day

Last modified on

2016 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027089


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name