UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the endoscopic findings of superficial elevated gastric lesions on magnifying endoscopy with narrow-band imaging
Title of the study (Brief title)	Endoscopic diagnosis of superficial elevated gastric lesions
Region	Japan

Condition
Condition	early gastric carcinomas, low-grade gastric adenomas
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the useful endoscopic findings of superficial elevated-type gastric epithelial neoplasias on magnyfing endoscopy with narrow-band imaging for differential diagnosis between early carcinomas and low-grade adenomas
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The useful optical signs on magnyfing endoscopy for discriminating between early carcinomas and low-grade adenomas
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	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Evaluation of superficial elevated-type gastric epithelial neoplasias on magnifying endoscopy with narrow-band imaging
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The superficial elevated-type gastric epithelial neoplasias which plan to be resected by endoscopic submucosal dissection at our institution
Key exclusion criteria	Advanced gastric carcinoma, co-existing advanced gastric carcinomas, co-existing carcinomas of any other organs, and a past history of surgical resection of the stomach are excluded
Target sample size	100

Research contact person
Name of lead principal investigator	Nonaka Takashi
Organization	Yokohama City University Hospital
Division name	Gastroenterology Division
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2640
Email	nonaka@yokohama-cu.ac.jp

Public contact
Name of contact person	Nonaka Takashi
Organization	Yokohama City University Hospital
Division name	Gastroenterology Division
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2640
Homepage URL
Email	nonaka@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital, Gastroenterology Division
Institute
Department

Funding Source
Organization	The Yokohama Foundation for Advancement of Medical Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiratsuka City Hospital, Department of Gastroenterology
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

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2015 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 22 Day
Last modified on	2016 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015116