UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of administration of vonoprazan after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma
Title of the study (Brief title)	Efficacy of vonoprazan after ESD for gastric neoplasms
Region	Japan

Condition
Condition	Gastric adenoma/carcinoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the efficacy and safety of administration of vonoprazan after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of the stage of scar at 4 weeks after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma (comparison of vonoprazan and esomeprazole as historical control group)
Key secondary outcomes	The diameter of the ulcer at 4 weeks after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma and relationship between these and patients background or lesion information (comparison of vonoprazan and esomeprazole as historical control group)

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma
Key exclusion criteria	Patients evaluated incompetent by doctors in attendance
Target sample size	50

Research contact person
Name of lead principal investigator	Makoto Arai
Organization	Chiba University Hospital
Division name	Gastroenterology
Address	Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL	043-226-2083
Email	araim-cib@umin.ac.jp

Public contact
Name of contact person	Daisuke Maruoka
Organization	Chiba University Hospital
Division name	Gastroenterology
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL	043-226-2083
Homepage URL
Email	maruoka-cib@umin.ac.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 25 Day
Anticipated trial start date	2015 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27492962
Results	Ulcer contraction rate at 4 weeks after ESD in the vonoprazan group was significantly higher than that of the esomeprazole group (97.7 +- 3.2% vs 94.5 +- 6.7%, respectively, P = 0.025), and 100% contraction rate tended to be higher in the vonoprazan group relative to the esomeprazole group (32% vs 13%, respectively, P = 0.070).
Other related information	Patients who have undergone endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma start to be administrated vonoprazan and undergo periodic endoscopy; be measured diameter of ulcer post ESD at 4 weeks after ESD.

Management information
Registered date	2015 Year 07 Month 02 Day
Last modified on	2017 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021048