UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of introduction ofgastric endoscopic submucosal dissection(ESD) by the gastric ESD beginners introduction after trining colorectal ESD
Title of the study (Brief title)	Safety and efficacy of introduction ofgastric endoscopic submucosal dissection(ESD) by the gastric ESD beginners introduction after trining colorectal ESD
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to assess the safety and efficacy of endoscopic submucosal dissection for gastric neoplasm by the gastric ESD beginners after training colorectal ESD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Completion rate
Key secondary outcomes	operation time,complication rate,number of mucosal injection,volume of mucosal injection,en bloc resection rate

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	treatment
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with early gastric cancer or gastric adenoma scheduled for endoscopic submucosal dissection from whom informed consent was obtained
Key exclusion criteria	1.Patients by whom infromed consent was not obtained 2.Pateints who have reccurent lesions
Target sample size	80

Research contact person
Name of lead principal investigator	Yohei Minato/Kouichi Nonaka
Organization	NTT Medical Centor Tokyo
Division name	Department of Gastoroenterology
Address	5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo
TEL	03-3448-6111
Email	yoheiminato55925@gmail.com

Public contact
Name of contact person	Yohei Minato
Organization	NTT Medical Centor Tokyo
Division name	Department of Gastoroenterology
Address	5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo
TEL	03-3448-6111
Homepage URL
Email	yoheiminato55925@gmail.com

Sponsor
Institute	NTT Medical Centor Tokyo
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	NTT Medical Centor Tokyo
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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 31 Day
Anticipated trial start date	2014 Year 12 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	2014 Year 11 Month 30 Day
Last modified on	2016 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017845