UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The multicenter randomized controlled trial on the effect of Helicobacter pylori eradication for endoscopic gastric submucosal dissection (ESD) after artificial ulcer healing
Title of the study (Brief title)	The multicenter randomized controlled trial on the effect of HP eradication in healing of artificial ulcer after ESD
Region	Japan

Condition
Condition	Patients have early gastric cancer endoscopic therapeutic indications lesions and adaptation expanding lesions, are Helicobacter pylori infection including the adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	I examine whether endoscopic gastric submucosal dissection is Helicobacter pylori (HP) eradication in healing after (ESD) artificial ulcer involved.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Artificial ulcer healing rate after ESD enforcement 56 days
Key secondary outcomes	Reduction ratio of ESD after artificial ulcer, adverse events incidence

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	do HP eradication after ESD
Interventions/Control_2	donot performed HP eradication after 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	Patients who agreed to participate in this study by the description document. 20 years of age and older adults. Patients Helicobacter pylori infection has been confirmed. Patient is determined to be the resected lesion in ESD. Patients adenoma or depth of invasion has been diagnosed with intramucosal cancer. Performance status is 0, 1, 2 patients.
Key exclusion criteria	Patients by narrowing and deformation of the upper gastrointestinal tract, drug administration and the endoscope insertion can be considered difficult. Patients with complications of active malignancy or other serious systemic. Patients with active ulcer. Serious complications, patients with (heart failure, renal failure than (creatinine clearance 60 (mL / min)), liver failure, respiratory failure). Patients on dialysis. Patients with a history of allergy to the study drug. Patients during pregnancy and lactation. Patients with a history of radiation therapy to the upper abdomen. Esophageal lesions, and patients who are scheduled for endoscopic therapy at the same time against duodenal lesions. Patients with registration history in this study. Patients who did not consent to participate in this clinical study. Others, patients who test responsibility (sharing) doctor has determined to be inappropriate as a subject.
Target sample size	130

Research contact person
Name of lead principal investigator	Makoto Sasaki
Organization	Aichi Medical University
Division name	Gastroenterology
Address	1-1 YazakoKarimata, Nagakute, Aichi 480-1195, Japan
TEL	0561-62-1508
Email	msasaki@aichi-med-u.ac.jp

Public contact
Name of contact person	Akihiro Shimozato
Organization	Aichi Medical University
Division name	Gastroenterology
Address	1-1 YazakoKarimata, Nagakute, Aichi 480-1195, Japan
TEL	0561-62-1508
Homepage URL
Email	shimozato.akihiro.274@mail.aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	Aichi Medical University
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	2015 Year 01 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 12 Month 10 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 02 Month 28 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 12 Day
Last modified on	2017 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018539