UMIN-CTR Clinical Trial

Basic information
Public title	Effect of acid suppressor in serum level of gastrin in Japanese patients with gastric ulcer after ESD
Acronym	Effect of acid suppressor in serum level of gastrin
Scientific Title	Effect of acid suppressor in serum level of gastrin in Japanese patients with gastric ulcer after ESD
Scientific Title:Acronym	Effect of acid suppressor in serum level of gastrin
Region	Japan

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

Objectives
Narrative objectives1	To clarify the difference in serum gastrin level after using acid suppressors
Basic objectives2	Others
Basic objectives -Others	To clarify the clinical features of patients who revealed the increased gastrin level after using PPI/P-Cab.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the difference in serum gastrin level after using acid suppressors
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient who received endoscopic submucosal dissection of early gastric cancer. 2) Patients whose sera were collected before and after using acid suppressors. 3) Patients with written informed consent. 4) Over 20 years.
Key exclusion criteria	1) Patients with allergic reaction for PPI/P-Cab. 2) Under 20 years old. 3) Patients with previous gasterectomy. 4) Patients with insufficient treatment by ESD.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Ito
Organization	Hiroshima University Hospital
Division name	Gastroenterology an Metabolism
Zip code	7348551
Address	1-2-3 Kasumi Minami-ku Hiroshima
TEL	+81-82-257-5191
Email	maito@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Ito
Organization	Hiroshima University Hospital
Division name	Gastroenterology an Metabolism
Zip code	7348551
Address	1-2-3 Kasumi Minami-ku Hiroshima
TEL	+81-82-257-5191
Homepage URL
Email	maito@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima university
Institute
Department

Funding Source
Organization	AstraZeneca
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for integrated medical research Hiroshima University Hospital
Address	1-2-3 Kasumi Minanmi-ku Hirosima
Tel	082-257-1752
Email	protocol@cimr.hiroshima-u.ac.jp

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	2019 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	150
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 01 Day
Date of IRB	2018 Year 12 Month 18 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2017 Year 12 Month 15 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034724