UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective multicenter trial for efficacy of potassium competitive acid blocker to reduce delayed bleeding after gastric endoscopic submucosal dissection in patients on antithrombotic therapy
Title of the study (Brief title)	Preventive effect of P-CAB for postoperative bleeding after gastric ESD
Region	Japan

Condition
Condition	Gastric neoplasm
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the preventive effect of P-CAB for postoperative bleeding in high-risk patients after gastric ESD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post-ESD bleeding rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Daily use of Vonoplazan (day 1 - 28)
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. Diagnosis of gastric adenoma or early gastric cancer satisfying the Japanese guideline criteria. 2. On antithrombotic therapy 3. 20 years or older 4. Performance status (ECOG) is 0, 1 or 2 5. With a written informed consent.
Key exclusion criteria	1. History of gastrectomy 2. Schedule of endoscopic treatment for esophageal or duodenal lesion concurrently. 3. History of endoscopic treatment for upper GI lesion in the past 28 days. 4. Schedule of endoscopic treatment for upper GI lesion within 28 days after the gastric ESD. 5. Systemic administration (intravenously or orally) of either one or more drugs of corticosteroid, anticoagulant agent. 6. Diagnosis of psychiatric diseases. 7. With active bacterial or fungus infection. 8. With uncontrollable hypertension. 9. Disqualified for the study by physicians.
Target sample size	50

Research contact person
Name of lead principal investigator	Tetsuo Takehara
Organization	Osaka university graduate school of medicine
Division name	Gastroenterology and hepatology
Address	Yamadaoka2-2, Suita, Osaka
TEL	06-6879-5111
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Yoshito Hayashi
Organization	Osaka university graduate school of medicine
Division name	Gastroenterology and hepatology
Address	Yamadaoka2-2, Suita, Osaka
TEL	06-6879-5111
Homepage URL
Email	y.hayashi@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka Gut Forum (OGF)
Institute
Department

Funding Source
Organization	n/a
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

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 09 Day
Anticipated trial start date	2015 Year 12 Month 24 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 12 Month 11 Day
Last modified on	2018 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023306