UMIN-CTR Clinical Trial

Basic information
Public title	Effects of H. pylori eradication therapy on the cure of stomach ulcer after endoscopic submucosal dissection
Acronym	ESD-eradication study
Scientific Title	Effects of H. pylori eradication therapy on the cure of stomach ulcer after endoscopic submucosal dissection
Scientific Title:Acronym	ESD-eradication study
Region	Japan

Condition
Condition	post ESD ulcer
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of H. pylori eradication therapy before ESD on the cure of post ESD ulcer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The ratio of ulceration area after 1 month of ESD compared with that of right after ESD
Key secondary outcomes	Cure rate of ulcers (4W, 8W after ESD) H. pylori eradication rate H. pylori infection rate Background of the patients Compliance of the medications

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Doing H. pylori eradication therapy before ESD
Interventions/Control_2	Not doing H. pylori eradication therapy before 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	The patients planned ESD due to early stomach cancer or suspicious of the cancer
Key exclusion criteria	Patients without H. pylori infection Patients with the history of gastric surgeries Patients with alarm symptoms such as vomiting, GI bleeding, rapid body weight loss Patients with alcohol/drug dependence Patients with severe endocrine problems Patients with severe injuries of heart, liver, kidney or bone marrow functions Patients with allergy against the test drugs Patients with pregnancy, possible pregnancy or breast feeding, or hope of pregnancy during the test period Patients whom the doctor decide as not proper for the study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masashi Matsushima
Organization	Tokai University School of Medicine
Division name	Internal Medicine (Gastroenterology)
Zip code
Address	143 Shomokasuya, Isehara, Kanagawa, Japan
TEL	0463-93-1121
Email	mmatsush@tokai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masashi Matsushima
Organization	Tokai University School of Medicine
Division name	Internal Medicine (Gastroenterology)
Zip code
Address	143 Shomokasuya, Isehara, Kanagawa, Japan
TEL	03-3370-2321
Homepage URL
Email	mmatsush@tok.u-tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	none
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
Address
Tel
Email

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	東海大学東京病院(東京都) Tokai University Tokyo Hospital 東海大学医学部付属病院(神奈川県) Tokai University Hospital 東海大学八王子病院（東京都） Tokai University Hachioji Hospital 東海大学大磯病院（神奈川県) Tokai University Oiso Hospital

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 30 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	Terminated
Date of protocol fixation	2012 Year 06 Month 15 Day
Date of IRB	2012 Year 07 Month 15 Day
Anticipated trial start date	2012 Year 07 Month 30 Day
Last follow-up date	2014 Year 12 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 07 Month 26 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010036