UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040641 |
|---|---|
| Receipt number | R000046386 |
| Scientific Title | Vonoprazan or Proton-pump inhibitor for gastric endoscopic submucosal dissection in patients under antithrombotic therapy: a randomized prospective multicenter study |
| Date of disclosure of the study information | 2020/06/03 |
| Last modified on | 2024/06/05 13:57:18 |
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Basic information
Public title
Vonoprazan or Proton-pump inhibitor for gastric endoscopic submucosal dissection in patients under antithrombotic therapy: a randomized prospective multicenter study
Acronym
V-POINT study
Scientific Title
Vonoprazan or Proton-pump inhibitor for gastric endoscopic submucosal dissection in patients under antithrombotic therapy: a randomized prospective multicenter study
Scientific Title:Acronym
V-POINT study
Region
| Japan |
Condition
Condition
gastric epithelial neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively assess the superiority of vonoprazan over classical proton pump inhibitors regarding the risk of delayed bleeding after gastric endoscopic submucosal dissection in patients under antithrombotic therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of bleeding within 8 weeks after ESD.
Key secondary outcomes
1. Frequency of GERD-like symptoms after ESD.
2. Frequency of pain after ESD.
3. Healing of the ulcer at 8 weeks after ESD.
4. Adverse events related to ESD.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will be randomly allocated to either VPZ or PPI group. In the PPI group, esomeprazole 20mg will be administered orally from the day before ESD to 54 days after ESD.
Interventions/Control_2
VPZ 20mg will be administered orally from the day before ESD to 54 days after ESD.
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. Gastric adenoma or early gastric cancer.
condition of early gastric cancer:
1) 2cm or smaller cT1a, well diff. UL0
2) larger than 2cm, cT1a, well diff.UL0
3) 3cm or smaller, cT1a, well diff. UL1
4) 2cm or smaller, cT1a, undiff. UL0
2. age 20 or older
3. PS=0,1,2
4. Laboratory data:
Hb 9g/dl or larger
Plt 100,000/mm3 or larger
AST, ALT 100 1U/l or less
PT-INR 80% or larger
5. Could be followed up for 56 days after ESD.
6. Those who gave written consent.
Key exclusion criteria
1. Those with simultaneous esophageal or duodenal endoscopic treatment.
2. Endoscopic treatment for upper digestive tract within 31 days before ESD.
3. Women with pregnancy,
4. Psychological disorders.
5. Presence of active infectious diseases.
6. Impossible to answer to F-Scale or VAS.
7. Allergy to VPZ or EPZ.
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Furukawa |
Organization
Nagoya University
Division name
Department of Gastroenterology & Hepatology, Nagoya University Graduate School of Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-2164
kazufuru@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Kakushima |
Organization
Nagoya University
Division name
Department of Gastroenterology & Hepatology, Nagoya University Graduate School of Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-2164
Homepage URL
n.kakushima@gmail.com
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
No funding source.
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
Nagoya University Graduate School of Medicine, IRB
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
+81-052-744-2973
ethics@med.nagoya-u.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
山下病院（愛知県）、名鉄病院（愛知県）、刈谷豊田総合病院（愛知県）、江南厚生病院（愛知県）、半田市立半田病院（愛知県）、名古屋第一赤十字病院（愛知県)、市立四日市病院（三重県）、静岡県立静岡がんセンター(静岡県)、石川県立中央病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 03 | 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
125
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
| 2020 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 16 | 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 | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046386
