UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictive factors of procedural difficulties in ESD (endoscopic submucosal dissection) of early-stage gastric cancer
Title of the study (Brief title)	Predictive factors of procedural difficulties in ESD
Region	Japan

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

Objectives
Narrative objectives1	To determine the usefulness of predictive factors of procedural difficulties in ESD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	A sensitivity and a specificity of predictive factors of procedural difficulties in 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	20 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Undergoing ESD 2) Aged 20-95 years
Key exclusion criteria	1) Severe co-morbidities 2) A history of gastric surgery
Target sample size	200

Research contact person
Name of lead principal investigator	Naoki Ohmiya
Organization	Fujita Health University School of Medicine
Division name	Department of Gastroenterology
Address	1-98 Dengakugakubo, Kutsukake-cho
TEL	0562-93-9240
Email	nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person	Naoki Ohmiya
Organization	Fujita Health University School of Medicine
Division name	Department of Gastroenterology
Address	1-98 Dengakugakubo, Kutsukake-cho
TEL	0562-93-9240
Homepage URL
Email	nohmiya@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine, Department of Gastroenterology
Institute
Department

Funding Source
Organization	Fujita Health 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	藤田保健衛生大学(愛知県)

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 03 Month 30 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	To determine the usefulness of predictive factors of procedural difficulties in ESD.

Management information
Registered date	2018 Year 03 Month 30 Day
Last modified on	2018 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036394