UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Helicobacter pylori eradication therapy on ulcer healing after gastric endoscopic submucosal dissection: a prospective randomized controlled trial.
Title of the study (Brief title)	Effects of eradication on gastric ESD
Region	Japan

Condition
Condition	Gastric cancer and gastric adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the benefit of H. pylori eradication before ESD to promote ulcer healing after the procedure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	state of ulcer healing on 28 days
Key secondary outcomes	bleeding after ESD

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Helicobacter pylori eradication before gastric ESD PPI-based triple therapy consisting of lansoprazole (60 mg), amoxicillin (1500 mg) and clarithromycin (400 mg)
Interventions/Control_2	Helicobacter pylori eradication after gastric 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Helicobacter pylori positive-patients with gastric cancer or gastric adenoma 1. Not less than 20 years old (no upper limit) 2.Written informed consent
Key exclusion criteria	1)using PPIs and H2RAs 2)using anti-coagulants 3)allergy to drugs 4)severe liver dysfunction 5)severe renal dysfunction 6)Pregnant or lactating women or women
Target sample size	150

Research contact person
Name of lead principal investigator	Shouko Ono
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Address	Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL	011-716-1161
Email	onosho@med.hokudai.ac.jp

Public contact
Name of contact person	Shouko Ono
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Address	N-14, W-5, Kita-ku, Sapporo
TEL	011-716-1161(5723)
Homepage URL
Email	onosho@med.hokudai.ac.jp

Sponsor
Institute	Division of Endoscopy, Hokkaido University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	北海道大学病院

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 09 Month 03 Day
Anticipated trial start date	2009 Year 10 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 04 Month 05 Day
Last modified on	2016 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000004172