UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Title of the study (Brief title)	Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Region	Japan

Condition
Condition	GI epithelial lesions
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Confocal laser endomicroscopy (CLE) is a newly established endoscopic method providing in vivo histology at a subcellular resolution during ongoing endoscopy. In this study, we will evaluate the safety of the technology and also conduct the CLE analysis of GI epithelial mucosal diseases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The procedural success rate of the visualization of the structure.
Key secondary outcomes	1) Comparing CLE findings with normal endoscopic findings, magnifying-endoscopic findings and pathological findings 2) Differential diagnosis 3) Image quality assessment. The evaluation criteria are divided into three(poor, almost invisible tissue structure; mild, visible tissue structure with too dark vision; good, clearly visible tissue structure). 4) Adverse events

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	Device,equipment
Interventions/Control_1	Transvenous administration of 10% solution or topical application of 0.1% fluorescein solution will be performed for tissue visualization with CLE. Then, the studied sites will be biopsied and the specimens will be histologically evaluated.
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 with suspected digestive disease such as a gastric carcinoma, gastric adenoma, colon carcinoma, colon adenoma.
Key exclusion criteria	1) Patients not indicated for normal endoscopy 2) History of allergy to fluorescein dye 3) Subjects with a severe comorbidity such as a diabetic disease, cardiovascular, neurologic dysfunction, cirrhosis of the liver, pheochromocytoma and pregnancy.
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuki Sumiyama
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Address	3-25-8, Nishi-Shinbashi, Minato-ku Tokyo
TEL	03-3433-1111(ext.3181)
Email	kaz_sum@jikei.ac.jp

Public contact
Name of contact person	Masakuni Kobayashi
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Address	3-25-8, Nishi-Shinbashi, Minato-ku Tokyo
TEL	03-3433-1111(ext.3181)
Homepage URL
Email	masakuni@jikei.ac.jp

Sponsor
Institute	Department of Endoscopy The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	nothing
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	東京慈恵会医科大学附属病院　内視鏡科

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 12 Month 21 Day
Anticipated trial start date	2013 Year 02 Month 01 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

Management information
Registered date	2013 Year 01 Month 11 Day
Last modified on	2018 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011396