UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of feasibility of non-exposed endoscopic wall-inversion surgery (NEWS) for gastric submucosal tumors
Title of the study (Brief title)	Feasibility study of NEWS for gastric submucosal tumor
Region	Japan

Condition
Condition	Submucosal tumor
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate feasibility and efficacy of non-exposed endoscopic wall-inversion surgery (NEWS) for gastric submucosal tumors 3 cm or less in size
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	3-year disease-specific survival rate
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Non-exposed endoscopic wall-inversion surgery (NEWS)
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	Patients having protruded or intraluminal type gastric submucosal tumor 3 cm or less without prior treatment
Key exclusion criteria	Patients possibly having severe adhesion at the port sites Submucosal tumor arising on the remnant stomach after gastrectomy
Target sample size	30

Research contact person
Name of lead principal investigator	Naohisa Yahagi
Organization	Keio University, School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Email	yahagi.keio.@gmail.com

Public contact
Name of contact person	Osamu Goto
Organization	Keio University, School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-5363-3437
Homepage URL
Email	ogotou-gi@keio.jp

Sponsor
Institute	Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University, School of Medicine
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 01 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 11 Month 07 Day
Anticipated trial start date	2013 Year 01 Month 29 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 01 Month 31 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019045