UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of endoscopic submucosal dissection for early gastric cancers using clip flap method.
Title of the study (Brief title)	Efficacy and safety of endoscopic submucosal dissection for early gastric cancers using clip flap method.
Region	Japan

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

Objectives
Narrative objectives1	This study is evaluated of efficacy and safety of endoscopic submucosal dissection for early gastric cancer using clip flap method.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Operative time, en blco resection rate and complications rate is evaluated.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Using clip flap method
Interventions/Control_2	Not using clip flap method
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	1. A case included in the adaptation of the ESD treatment that followed "stomach cancer treatment guidelines" 2. A case of 20 years or older 3. A case that Performance status (ECOG) is 0, 1 or 2
Key exclusion criteria	1. A case having serious complications (heart failure, renal failure, liver failure, respiratory failure) 2. A case that it was not agree by the participation in this clinical study
Target sample size	100

Research contact person
Name of lead principal investigator	Akira Andoh
Organization	Shiga University of Medical Science
Division name	Divison of Gastroenterology
Address	Seta Tsukinowa-cho ,Otsu, Shiga
TEL	077-548-2217
Email	Andoh@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hiromitsu Ban
Organization	Shiga University of Medical Science
Division name	Division of Digestive Endoscopy
Address	Seta Tsukinowa-cho ,Otsu, Shiga
TEL	077-548-2217
Homepage URL
Email	hban@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	滋賀医科大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 05 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 07 Month 05 Day
Last modified on	2018 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=R000021072