UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011138 |
|---|---|
| Receipt number | R000012957 |
| Scientific Title | Effects and cost-effectiveness of proton pump inhibitor by oral versus injection after endoscopic submucosal dissection |
| Date of disclosure of the study information | 2013/07/07 |
| Last modified on | 2021/05/24 19:25:24 |
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Basic information
Public title
Effects and cost-effectiveness of proton pump inhibitor by oral versus injection after endoscopic submucosal dissection
Acronym
Effects and cost-effectiveness of proton pump inhibitor by oral versus injection after endoscopic submucosal dissection
Scientific Title
Effects and cost-effectiveness of proton pump inhibitor by oral versus injection after endoscopic submucosal dissection
Scientific Title:Acronym
Effects and cost-effectiveness of proton pump inhibitor by oral versus injection after endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
gastric tumor(gastric cancer ,gastric adenoma)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effects of the proton pump inhibitor by oral versus injection after ESD.If there are no difference between the two groups,we assess the cost containment.
Basic objectives2
Others
Basic objectives -Others
medical cost
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of the post-ESD bleeding rate, and the area of ulcer-healing area between two groups after the ESD for 28 days and 56 days
Key secondary outcomes
The difference of cost performance of the proton pump inhibitor, average number of hospitalization days, between by injection and oral.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients of oral gruops are received rabeprazole 10mg twice a day by oral for two days from ESD procedure
Interventions/Control_2
Patients of injection gruops are received lansoprazole 30mg twice a day intravenously for two days from ESD procedure
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria are patients with early gastric cancer,gastric adenoma,or suspected gastric neoplasm who are received ESD procedure in Kagawa University.
Key exclusion criteria
Patients who can not receive oral administration
history of gastric or esophageal surgery
drug allergy
major organ failure such as cardiac or pulmonary complications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohito Mori |
Organization
Kagawa university
faculuty of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1750-1 ,Miki-cho,Kita-gun,Kagawa Prefecture,761-0793 Japan
TEL
+81-87-891-2156
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kagawa university
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1750-1 ,Miki-cho,Kita-gun,Kagawa Prefecture,761-0793 Japan
TEL
+81-87-891-2156
Homepage URL
Sponsor or person
Institute
Kagawa university
faculuty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kagawa university
faculuty of Medicine
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 | 07 | Month | 07 | 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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 07 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012957
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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