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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041299
Receipt No. 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 2020/08/03

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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
Email 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
Email daisuto@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare Hospital
Institute
Department

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
Email 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
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
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
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 03 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047161

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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