UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022269 |
|---|---|
| Receipt number | R000025661 |
| Scientific Title | The effectiveness of Vonoprazan for ulcer healing and prevention of delayed bleeding after gastric ESD: a prospective observational study. |
| Date of disclosure of the study information | 2016/05/11 |
| Last modified on | 2019/11/26 17:49:17 |
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Basic information
Public title
The effectiveness of Vonoprazan for ulcer healing and prevention of delayed bleeding after gastric ESD: a prospective observational study.
Acronym
The effectiveness of Vonoprazan for ulcer healing and prevention of delayed bleeding after gastric ESD.
Scientific Title
The effectiveness of Vonoprazan for ulcer healing and prevention of delayed bleeding after gastric ESD: a prospective observational study.
Scientific Title:Acronym
The effectiveness of Vonoprazan for ulcer healing and prevention of delayed bleeding after gastric ESD.
Region
| Japan |
Condition
Condition
Gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study was to assess the effectiveness of Vonoprazan for ulcer healing and delayed bleeding after ESD during perioperative period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the rate of delayed bleeding after ESD by Vonoprazan at 6 weeks, compared with proton pomp inhibitor at 8 weeks.
Key secondary outcomes
To assess the rate of ulcer healing after ESD by Vonoprazan at 6 weeks, compared with proton pomp inhibitor at 8 weeks.
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) Diagnosed gastric cancer as clinical T1a or gastric adenoma
(2) Only one lesion will be performed by ESD.
(3) Patients are accepted to enrollment and registration for this study.
(4) Patients can be follow up for 56 days after ESD.
Key exclusion criteria
(1) Patients with active peptic ulcer
(2) Patients with the history of gastrectomy
(3) The lesion which are recurrence of endoscopic resection before
(4) Patients with intake of mucosal protective agent or antacid
(5) Patients with severe anemia
(6) Patients with severe liver dysfunction
(7) Patients with severe renal dysfunction
(8) Patients with allergy for Vonoprazan
(9) Patients without written informed consent
(10) Patients with the possibility of the pregnancy or the pregnancy and lactating
(11) Ineligible patients certified by doctors
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee of Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2016 | Year | 05 | Month | 11 | 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
| 2016 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 06 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
The primary aim of this study was to assess the effectiveness of Vonoprazan for ulcer healing and delayed bleeding after ESD during perioperative period. To assess the rate of ulcer healing and delayed bleeding after ESD by Vonoprazan at 6 weeks, compared with proton pomp inhibitor at 8 weeks
Management information
Registered date
| 2016 | Year | 05 | Month | 11 | Day |
Last modified on
| 2019 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025661
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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