UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Short-term ulcer healing induced by P-CAB following gastric endoscopic submucosal dissection:a propensity score analysis
Title of the study (Brief title)	Short-term ulcer healing induced by P-CAB following gastric endoscopic submucosal dissection
Region	Japan

Condition
Condition	early gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	clarify the effect of vonoprazan on promoting ESD-related ulcer healing compared with lansoprazole for 14 days
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the ulcer reduction ratio 14 days after ESD
Key secondary outcomes

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	the gastric cancers adhering to the expanded criteria
Key exclusion criteria	a history of prior surgery, lesions with scars), lesions with a steroid injection, postoperative bleeding, an additional surgery, lost to follow-up
Target sample size	100

Research contact person
Name of lead principal investigator	Yohei Horikawa
Organization	Hiraka General Hospital
Division name	Gastroenterology
Address	Maego, Yatsukuchi, 3-1, Yokote city
TEL	0182-32-5121
Email	horikawa_01@me.com

Public contact
Name of contact person	Yohei Horikawa
Organization	Hiraka General Hospital
Division name	Gastroenterology
Address	Maego, Yatsukuchi, 3-1, Yokote city
TEL	0182-32-5121
Homepage URL
Email	horikawa_01@me.com

Sponsor
Institute	Hiraka General Hospital
Institute
Department

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 03 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2017 Year 10 Month 01 Day
Date of closure to data entry	2017 Year 10 Month 01 Day
Date trial data considered complete	2017 Year 10 Month 01 Day
Date analysis concluded	2017 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	nothing

Management information
Registered date	2017 Year 03 Month 03 Day
Last modified on	2018 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030325