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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029300
Receipt No. R000032794
Scientific Title The effectiveness of Vonoprazan for delayed bleeding after ESD in antithrombotic drug-users: a prospective study.
Date of disclosure of the study information 2017/10/01
Last modified on 2018/10/18

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Basic information
Public title The effectiveness of Vonoprazan for delayed bleeding after ESD in antithrombotic drug-users: a prospective study.
Acronym The effectiveness of Vonoprazan for delayed bleeding after ESD in antithrombotic drug-users: a prospective study.
Scientific Title The effectiveness of Vonoprazan for delayed bleeding after ESD in antithrombotic drug-users: a prospective study.
Scientific Title:Acronym The effectiveness of Vonoprazan for delayed bleeding after ESD in antithrombotic drug-users: a prospective study.
Region
Japan

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

Objectives
Narrative objectives1 evaluate the effectiveness of Vonoprazan for delayed bleeding after ESD in antithrombotic drug-users
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the rate of delayed bleeding after ESD
Key secondary outcomes the rate of thromboembolism, bleeding event which are not assosiated with ESD(cerebral hemorrhage, gastrointestinal bleeding), the need for blood transfusion,the days of hospitalization, mortality

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 prescription of vonoprazan
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)antithrombotic drug-users
2)criteria and expanded criteria for gastric ESD
3)withdrawal antithrombotic drug in accordance with the guidelines-Japan Gastroenterological Endoscopy Society
Key exclusion criteria 1)perforation during ESD
2)allergy for vonoprazan
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name hiroshi takayama
Organization kurashiki central hospital
Division name gastroenterology
Zip code
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 086-422-0210
Email igakuken@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name hiroshi takayama
Organization kurashiki central hospital
Division name gastroenterology
Zip code
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 086-422-0210
Homepage URL
Email ht14835@kchnet.or.jp

Sponsor
Institute kurashiki central hospital
Institute
Department

Funding Source
Organization kurashiki central hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 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
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
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 26 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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