UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study
Title of the study (Brief title)	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	Fumihito Hirai
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Gastroenterology
Address	1-1-1 Zokumyoin Chikushino Fukuoka
TEL	092-921-1011
Email	syokaki@fukuoka-u.ac.jp

Public contact
Name of contact person	Kazutomo Yamasaki
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Gastroenterology
Address	1-1-1 Zokumyoin Chikushino Fukuoka
TEL	092-921-1011
Homepage URL
Email	syokaki@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027089