UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051117 |
|---|---|
| Receipt number | R000058300 |
| Scientific Title | A study of endoscopic observations of early gastric cancer at three weeks after vonoprazan following endoscopic therapy |
| Date of disclosure of the study information | 2023/05/22 |
| Last modified on | 2023/05/21 13:08:16 |
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Basic information
Public title
A study of endoscopic observations of early gastric cancer at three weeks after vonoprazan following endoscopic therapy
Acronym
A study of endoscopic observations of early gastric cancer at three weeks after vonoprazan following endoscopic therapy
Scientific Title
A study of endoscopic observations of early gastric cancer at three weeks after vonoprazan following endoscopic therapy
Scientific Title:Acronym
A study of endoscopic observations of early gastric cancer at three weeks after vonoprazan following endoscopic therapy
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
After endoscopic treatment of early gastric cancer, proton pump inhibitors or vonoprazan are commonly used to suppress gastric acid secretion in order to form artificial gastric ulcers. However, there is no consensus on the appropriate duration of treatment, and gastric acid secretion inhibitors are usually taken for two months after endoscopic treatment. Recently, however, there have been reports of patients discontinuing vonoprazan after three weeks. However, there have been no studies of cases in which the area of dissection increases after endoscopic treatment of early gastric cancer. In this study, esophagogastroduodenoscopy will be performed three weeks after endoscopic treatment of early gastric cancer to confirm the healing status of ulcers after endoscopic treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
esophagogastroduodenoscopy three weeks after endoscopic treatment to evaluate the size of post-endoscopic ulcer, evaluation of ulcer according to the Sakita-Miwa classification.
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Endoscopic treatment indications
Key exclusion criteria
Patients over 90 years of age, patients unable to give consent, other patients considered inappropriate for treatment, and patients with contraindications to vonoprazan.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Suto |
Organization
International University of Health and Welfare Hospital
Division name
Department of Gastroenterology
Zip code
329-2763
Address
537-3, Iguchi, Nasushiobara, Tochigi 329-2763, Japan
TEL
0287-39-3060
daisuto@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Suto |
Organization
International University of Health and Welfare Hospital
Division name
Department of Gastroenterology
Zip code
329-2763
Address
537-3, Iguchi, Nasushiobara, Tochigi 329-2763, Japan
TEL
0287-39-3060
Homepage URL
daisuto@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
International University of Health and Welfare Hospital
Address
537-3, Iguchi, Nasushiobara, Tochigi 329-2763, Japan
Tel
0287-39-3060
daisuto@iuhw.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
| 2023 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n this study, esophagogastroduodenoscopy will be performed three weeks after endoscopic treatment of early gastric cancer to confirm ulcer healing status after endoscopic treatment.
Management information
Registered date
| 2023 | Year | 05 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058300
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
