UMIN-CTR Clinical Trial

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	210

Research contact person
Name of lead principal investigator	1st name Mitsuhiro Middle name Last name Fujishiro
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
Email	mtfujish@gmail.com

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
Email	kakushin-tky@umin.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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
Email	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）

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
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	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	2020 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046386

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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