UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of Vonoprazan for ulcer healing and prevention of delayed bleeding after gastric ESD: a prospective observational study.
Acronym	The effectiveness of Vonoprazan for ulcer healing and prevention of delayed bleeding after gastric ESD.
Scientific Title	The effectiveness of Vonoprazan for ulcer healing and prevention of delayed bleeding after gastric ESD: a prospective observational study.
Scientific Title:Acronym	The effectiveness of Vonoprazan for ulcer healing and prevention of delayed bleeding after gastric ESD.
Region	Japan

Condition
Condition	Gastric tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The primary aim of this study was to assess the effectiveness of Vonoprazan for ulcer healing and delayed bleeding after ESD during perioperative period.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To assess the rate of delayed bleeding after ESD by Vonoprazan at 6 weeks, compared with proton pomp inhibitor at 8 weeks.
Key secondary outcomes	To assess the rate of ulcer healing after ESD by Vonoprazan at 6 weeks, compared with proton pomp inhibitor at 8 weeks.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Diagnosed gastric cancer as clinical T1a or gastric adenoma (2) Only one lesion will be performed by ESD. (3) Patients are accepted to enrollment and registration for this study. (4) Patients can be follow up for 56 days after ESD.
Key exclusion criteria	(1) Patients with active peptic ulcer (2) Patients with the history of gastrectomy (3) The lesion which are recurrence of endoscopic resection before (4) Patients with intake of mucosal protective agent or antacid (5) Patients with severe anemia (6) Patients with severe liver dysfunction (7) Patients with severe renal dysfunction (8) Patients with allergy for Vonoprazan (9) Patients without written informed consent (10) Patients with the possibility of the pregnancy or the pregnancy and lactating (11) Ineligible patients certified by doctors
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	602-8566
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Email	ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Osamu Middle name Last name Dohi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	602-8566
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Homepage URL
Email	osamu-d@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
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	Ethical Review Committee of Kyoto Prefectural University of Medicine
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
Tel	075-251-5337
Email	rinri@koto.kpu-m.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	2016 Year 05 Month 11 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	Completed
Date of protocol fixation	2016 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date	2016 Year 11 Month 28 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 10 Month 31 Day
Date trial data considered complete	2018 Year 11 Month 06 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information	The primary aim of this study was to assess the effectiveness of Vonoprazan for ulcer healing and delayed bleeding after ESD during perioperative period. To assess the rate of ulcer healing and delayed bleeding after ESD by Vonoprazan at 6 weeks, compared with proton pomp inhibitor at 8 weeks

Management information
Registered date	2016 Year 05 Month 11 Day
Last modified on	2019 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025661