UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029300 |
|---|---|
| Receipt number | 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 19:16:38 |
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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
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
ht14835@kchnet.or.jp
Sponsor or person
Institute
kurashiki central hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032794
