UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048996 |
|---|---|
| Receipt number | R000055816 |
| Scientific Title | Clinical outcomes of patients receiving oral vonoprazan therapy vs. intravenous and oral proton pump inhibitor therapy after endoscopic submucosal dissection for gastric neoplasms: a prospective observational study |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2023/10/30 20:28:05 |
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Basic information
Public title
Clinical outcomes of patients receiving oral vonoprazan therapy vs. intravenous and oral proton pump inhibitor therapy after endoscopic submucosal dissection for gastric neoplasms: a prospective observational study
Acronym
Clinical outcomes of patients receiving oral vonoprazan therapy after endoscopic gastric submucosal dissection
Scientific Title
Clinical outcomes of patients receiving oral vonoprazan therapy vs. intravenous and oral proton pump inhibitor therapy after endoscopic submucosal dissection for gastric neoplasms: a prospective observational study
Scientific Title:Acronym
Clinical outcomes of patients receiving oral vonoprazan therapy after endoscopic gastric submucosal dissection
Region
| Japan |
Condition
Condition
Gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validity of oral vonoprazan therapy from the day of endoscopic gastric submucosal dissection by comparing the postoperative bleeding rate between patients receiving oral vonoprazan therapy and those receiving intravenous and oral proton pump inhibitor therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative bleeding rate
Key secondary outcomes
Ulcer healing rate(8 weeks +- 1 week after endoscopic submucosal dissection)and cost savings
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients indicated for endoscopic submucosal dissection according to the guidelines for endoscopic submucosal dissection and endoscopic mucosal resection for early gastric cancer (second edition)
Key exclusion criteria
Cases of preoperatively suspected invasive cancer deeper than the submucosa
Cases of intraoperative perforation
Pregnant or lactating women
History of allergy to vonoprazan
Cases deemed unsuitable for this study by the researchers
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Miyaoka |
Organization
Kurashiki Central Hospital
Division name
Gastroenterology and Hepatology
Zip code
710-8602
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
+81864220210
dm15697@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Miyaoka |
Organization
Kurashiki Central Hospital
Division name
Gastroenterology and Hepatology
Zip code
710-8602
Address
1-1-1, Miwa, Kurashiki, Okayama
TEL
+81864220210
Homepage URL
dm15697@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Non
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
Kurashiki Clinical Research Institute
Address
1-1-1, Miwa, Kurashiki, Okayama
Tel
+81864220210
kenkyu@kchnet.or.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
| 2022 | Year | 09 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Non
Management information
Registered date
| 2022 | Year | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055816
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
