UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Factors affects ulcer healing after gastric endoscopic submucosal dissection
Title of the study (Brief title)	Factors affects ulcer healing after gastric endoscopic submucosal dissection
Region	Japan

Condition
Condition	superficial gastric neoplasm
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the factor affecting ulcer healing after gastric-ESD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ulcer reduction rate
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.cancers referring to the expanded criteria 2.cancers excluded by the above criteria that were treated at patient's request 3. gastric adenomas that were difficult to distinguish from cancer.
Key exclusion criteria	(1) experienced delayed bleeding, (2) required additional surgery, (3) had previous surgery, (4) were lost to follow-up, (5) required steroid injection to prevent stenosis, or (6) had poor compliance with oral administration of the study drugs (> 20%).
Target sample size	300

Research contact person
Name of lead principal investigator	Yohei Horikawa
Organization	Hiraka General Hospital
Division name	Gastroenterology
Address	Maego 3-1, Yatsukuchi, Yokote city
TEL	0182-32-5121
Email	horikawa_01@me.com

Public contact
Name of contact person	Yohei Horikawa
Organization	Hiraka General Hospital
Division name	Gastroenterology
Address	Maego 3-1, Yatsukuchi, Yokote city
TEL	0182-32-5121
Homepage URL
Email	horikawa_01@me.com

Sponsor
Institute	Hiraka General Hospital
Institute
Department

Funding Source
Organization	nothing
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	2015 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 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	Published
URL releasing results
Results
Other related information	measuring ulcer size at endoscopy on 4W/8W after ESD

Management information
Registered date	2014 Year 12 Month 31 Day
Last modified on	2016 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018408