UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The retrospective study investigating safety and prognsis of gastric ESD for the elderly people.
Title of the study (Brief title)	The investigation of gastric ESD for the elderly people.
Region	Japan

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

Objectives
Narrative objectives1	To investigation of safety and prognosis of gastric ESD for the elderly.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The prognosis of the elderly performed gastric ESD.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male
Key inclusion criteria	patients who unederwent gastric ESD in Chiba university hospital
Key exclusion criteria	nothing particular
Target sample size	150

Research contact person
Name of lead principal investigator	Makoto Arai
Organization	Chiba university hospital
Division name	Department of gastroenterology in Chiba university hospital
Address	1 8 1 Inohana Cyuo ward Chiba city
TEL	043-222-7171
Email	araim-cib@umin.ac.jp

Public contact
Name of contact person	Makoto Arai
Organization	Chiba university
Division name	gastroenterology and neohrology
Address	1 8 1 Inohana Cyuo ward Chiba city
TEL	043-222-7171
Homepage URL
Email	araim-cib@umin.ac.jp

Sponsor
Institute	Department of gastroenterology in Chiba university
Institute
Department

Funding Source
Organization	Chiba university
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	2016 Year 11 Month 16 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 11 Month 07 Day
Anticipated trial start date	2016 Year 11 Month 07 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	patients from 2005 who underwent gastric ESD would be included.

Management information
Registered date	2016 Year 11 Month 16 Day
Last modified on	2016 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028605