UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003448 |
|---|---|
| Receipt number | R000004172 |
| Scientific Title | Effects of Helicobacter pylori eradication therapy on ulcer healing after gastric endoscopic submucosal dissection: a prospective randomized controlled trial. |
| Date of disclosure of the study information | 2010/04/06 |
| Last modified on | 2016/04/05 17:57:55 |
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Basic information
Public title
Effects of Helicobacter pylori eradication therapy on ulcer healing after gastric endoscopic submucosal dissection: a prospective randomized controlled trial.
Acronym
Effects of eradication on gastric ESD
Scientific Title
Effects of Helicobacter pylori eradication therapy on ulcer healing after gastric endoscopic submucosal dissection: a prospective randomized controlled trial.
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Shouko Ono |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL
011-716-1161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shouko Ono |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
N-14, W-5, Kita-ku, Sapporo
TEL
011-716-1161(5723)
Homepage URL
onosho@med.hokudai.ac.jp
Sponsor or person
Institute
Division of Endoscopy, Hokkaido 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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 06 | 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
| 2009 | Year | 09 | Month | 03 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004172
