UMIN-CTR Clinical Trial

Basic information
Public title	The study of endocytoscopic observation for esophageal squamous lesions
Acronym	endocytoscopic observation for esophageal squamous lesions
Scientific Title	The study of endocytoscopic observation for esophageal squamous lesions
Scientific Title:Acronym	endocytoscopic observation for esophageal squamous lesions
Region	Japan

Condition
Condition	esophageal squamous lesions
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the acquisition rate of appropriate endocytoscopic figures for the brownish area found by narrow band imaging in esophagus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the acquisition rate of appropriate endocytoscopic figures
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	endocytoscopy with narrow band imaging
Interventions/Control_2	endocytoscopy without narrow band imaging
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	i) age over 20 ii) brownish area within 20mm in esophagus found by narrow band imaging iii) written informed consent
Key exclusion criteria	1)Patients with prior chemotherapy or radiotherapy to the esophagus ii)refusal of written informed consent
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Keitaro Middle name Last name Takahashi
Organization	Asahikawa medical university
Division name	Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology
Zip code	078-8510
Address	2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
TEL	0166-68-2462
Email	ktakaha@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Keitaro Middle name Last name Takahashi
Organization	Asahikawa medical university
Division name	Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology
Zip code	078-8510
Address	2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
TEL	0166-68-2462
Homepage URL
Email	ktakaha@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa medical university
Institute
Department

Funding Source
Organization	Asahikawa medical university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asahikawa medical university
Address	2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
Tel	0166-68-2462
Email	ktakaha@asahikawa-med.ac.jp

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	2021 Year 11 Month 01 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	Open public recruiting
Date of protocol fixation	2021 Year 10 Month 28 Day
Date of IRB	2021 Year 11 Month 05 Day
Anticipated trial start date	2021 Year 12 Month 01 Day
Last follow-up date	2026 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 28 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052391