UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study about the utility of ultrathin endoscopy with FICE for early gastric neoplasms.
Title of the study (Brief title)	The utility of ultrathin endoscopy with FICE for early gastric neoplasms.
Region	Japan

Condition
Condition	early gastric neoplasms
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the detectability of the ultrathin endoscopy with FICE
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The evaluation about the images of the ultrathin endoscopy with FICE to conventional endoscopy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
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	Observation for early gastric cancers with convenional endoscopy
Interventions/Control_2	Observation for early gastric cancers with ultrathin endoscopy
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients underwent ESD for early gastric cancers
Key exclusion criteria	Cases with severe complication are excluded
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshiki Hirooka
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
Address	65, Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan
TEL	052-744-2172
Email	kc-y@med.nagoya-u.ac.jp

Public contact
Name of contact person	Takafumi Yokoyama
Organization	Nagoya University Hosp
Division name	Department of Gastroenterology
Address	65, Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan
TEL	052-744-2172
Homepage URL
Email	kc-y@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterology, Nagoya University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 19 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 03 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	2015 Year 06 Month 19 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019926