UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective trial of esomeprazole effect on the healing process of post-gastric endscopic submucosal dissection (ESD) ulcers
Title of the study (Brief title)	efficacy of esomeprazole for post-ESD ulcers
Region	Japan

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

Objectives
Narrative objectives1	To investigate the healing rate of post ESD ulcers in response to the esomeprazole(20mg/day) treatment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the healing rates of post-ESD ulcers at 4, 8 weeks after ESD
Key secondary outcomes	the rate of post-ESD bleeding with emergent endoscopy

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who will undergo ESD for gastric neoplasms at Tsuchiura kyodo hospital
Key exclusion criteria	1)Patients who are pregnant or nursing 2)Drug allergy for esomeprazole 3)Patients who are diagnosed as unsuitable for this trial by investigator
Target sample size	100

Research contact person
Name of lead principal investigator	Takashi Ichida
Organization	Tsuchiura kyodo hospital
Division name	Division of gastroenterology
Address	11-7, Manabeshinmachi, Tsuchiura City, Japan
TEL	0298303711
Email	taka_taka0621@yahoo.co.jp

Public contact
Name of contact person	Takashi Ichida
Organization	Tsuchiura kyodo hospital
Division name	Division of gastroenterology
Address	11-7, Manabeshinmachi, Tsuchiura City, Japan
TEL	029-823-3111
Homepage URL
Email	taka_taka_0621@yahoo.co.jp

Sponsor
Institute	Tsuchiura kyodo hospital
Institute
Department

Funding Source
Organization	Tsuchiura kyodo hospital
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	2013 Year 11 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 10 Day
Anticipated trial start date	2013 Year 11 Month 19 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	none

Management information
Registered date	2012 Year 11 Month 20 Day
Last modified on	2017 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011007