UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Healing effect of a Vonoprazan or a Lansoprazole for artificial ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial.
Title of the study (Brief title)	Healing effect of P-CAB for artificial ulcer after ESD.
Region	Japan

Condition
Condition	early gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	It is aimed for the decision of appropriate gastric secretion inhibitors for artificial ulcer after endoscopic submucosal dissection in consideration of the CYP2C19 polymorphism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The healing rate of artificial ulcer after endoscopic submucosal dissection is evaluated.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eradication of H. pylori before ESD. Vonoprazan is given after ESD.
Interventions/Control_2	Eradication of H. pylori before ESD. Lansoprazole is given after ESD.
Interventions/Control_3	No eradication of H. pylori before ESD. Vonoprazan is given after ESD.
Interventions/Control_4	No eradication of H. pylori before ESD. Lansoprazole is given after ESD.
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. A case included in the adaptation of the ESD treatment that followed "stomach cancer treatment guidelines" 2. A case of H.pylori-positive 3. A case of 20 years or older 4. A case that Performance status (ECOG) is 0, 1 or 2
Key exclusion criteria	1. A case that takes steroid more than 15 mg 2. A case having serious complications (heart failure, renal failure, liver failure, respiratory failure) 3. A case to have an allergy career to a study drug 4. A case that it was not agree by the participation in this clinical study
Target sample size	200

Research contact person
Name of lead principal investigator	Akira Andoh
Organization	Shiga University of Medical Science
Division name	Divison of Gastroenterology
Address	Seta Tsukinowa-cho ,Otsu, Shiga
TEL	077-548-2217
Email	Andoh@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hiromitsu Ban
Organization	Shiga University of Medical Science
Division name	Division of Digestive Endoscopy
Address	Seta Tsukinowa-cho ,Otsu, Shiga
TEL	077-548-2217
Homepage URL
Email	hban@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	None
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	滋賀医科大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 07 Day
Anticipated trial start date	2015 Year 07 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

Management information
Registered date	2015 Year 07 Month 04 Day
Last modified on	2018 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021063