UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041299 |
|---|---|
| Receipt number | R000047161 |
| Scientific Title | Attempt to raise the pH of gastric juice during gastric ESD |
| Date of disclosure of the study information | 2020/08/04 |
| Last modified on | 2023/08/05 13:59:19 |
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Basic information
Public title
Attempt to raise the pH of gastric juice during gastric ESD
Acronym
Attempt to raise the pH of gastric juice during gastric ESD
Scientific Title
Attempt to raise the pH of gastric juice during gastric ESD
Scientific Title:Acronym
Attempt to raise the pH of gastric juice during gastric ESD
Region
| Japan |
Condition
Condition
gastric csncer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Tests related to gastric acid secretion, such as basal secretion (BAO), followed by a post-stimulant maximal secretion test (MAO) and a pH monitor, are performed, but they are somewhat invasive. In recent years, with the increase in the use of endoscopy, the proportion of gastric cancer cases detected at an early stage has increased and the number of endoscopic submucosal dissection procedures has also increased. On the other hand, however, with the aging population, bleeding after endoscopic treatment, especially endoscopic submucosal dissection, is a growing concern. It is well known that neither platelet aggregation nor plasma coagulation occurs at a gastric juice pH below 5.3. Conventional gastric acid secretion inhibitors (PPIs) require several days to reach a high pH level, while the recently introduced bonoprazan is said to raise the pH level within a few hours after administration. However, the recent introduction of Bonoprazan has been reported to raise the pH of gastric juice a few hours after endoscopy. In this study, we examined intragastric pH, post-endoscopic gastric bleeding, post-endoscopic ulcer healing tendency, and ulcer size by collecting gastric fluid samples at the time of endoscopic treatment after oral Bonoprazan was administered from the day before endoscopic treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
On the day of ESD, gastric juice is collected and measured for pH before the endoscopic procedure, and an upper gastrointestinal endoscopy is performed the day after the completion of ESD and at 2 months to confirm the size and healing of the ulcer after endoscopic treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The day before gastric ESD, vonoprazan 20 mg/day is taken after dinner and ESD is performed.
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
Patients diagnosed with early-stage gastric cancer or gastric adenoma by upper gastrointestinal endoscopy, who are indicated for endoscopic treatment and who are not taking vonoprazan or H2A by oral medication are eligible.
Key exclusion criteria
Exclude people who are already taking PPIs
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yoshida |
Organization
International University of Health and Welfare Hospital
Division name
Department of Surgery
Zip code
329-2763
Address
537-3, Iguchi, Nasushiobara, Tochigi 329-2763, Japan
TEL
0287-39-3060
masashi@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
International University of Health and Welfare Hospital
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
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
| 2020 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7578543/pdf/main.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7578543/pdf/main.pdf
Number of participants that the trial has enrolled
18
Results
There were 14 cases of post-ESD bleeding in patients treated with proton-pump inhibitors (PPIs), including oozing during second-look endoscopy compared to only 1 case of bleeding with vonoprazan administration. Vonoprazan was also associated with better post-ESD ulcer healing than PPIs. Gastric pH during ESD after vonoprazan administration on the night before gastric ESD was 6.96 in all 11 patients.
Results date posted
| 2023 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 07 | Day |
Baseline Characteristics
Patient undergoing endoscopic submucosal dissection for early gastric cancer but not taking gastric acid secretion inhibitors
Participant flow
Patient undergoing endoscopic submucosal dissection for early gastric cancer but not taking gastric acid secretion inhibitors
Adverse events
None
Outcome measures
Measurement of gastric juice PH
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 05 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047161
