UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009597
Receipt number R000011257
Scientific Title Effects of H. pylori eradication therapy on the Healing of Gastric ulcer after endoscopic mucosal resection/submucosal dissection
Date of disclosure of the study information 2013/01/01
Last modified on 2012/12/20 20:03:33

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Basic information

Public title

Effects of H. pylori eradication therapy on the Healing of Gastric ulcer after endoscopic mucosal resection/submucosal dissection

Acronym

EMR/ESD HP eradication

Scientific Title

Effects of H. pylori eradication therapy on the Healing of Gastric ulcer after endoscopic mucosal resection/submucosal dissection

Scientific Title:Acronym

EMR/ESD HP eradication

Region

Japan


Condition

Condition

Early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of H. pylori eradication therapy just after EMR/ESD on the healing of post EMR/ESD ulcer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The ratio of ulceration area after 4weeks and 16weeks of EMR/ESD compared with that of right after ESD

Key secondary outcomes



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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

H.pylori eradication therapy just after EMR/ESD.

Interventions/Control_2

No H.pylori eradication therapy.

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 who are going to undergo EMR/ESD due to early gastric cancer.

Positive for Helicobacter pylori.
Obtained Written informed consent.

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

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuji Takayama

Organization

Tokushima university hospital

Division name

Department of gastroenterology and oncology

Zip code


Address

3-18-15,Kuramoto-cho,Tokushima city

TEL

0886337124

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokushima university hospital

Division name

Department of gastroenterology and oncology

Zip code


Address


TEL


Homepage URL


Email

awachiken@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima university hospital

Institute

Department

Personal name



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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 01 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

Preinitiation

Date of protocol fixation

2012 Year 12 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 12 Month 20 Day

Last modified on

2012 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011257


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name