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
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
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
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
