UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011487 |
|---|---|
| Receipt number | R000013443 |
| Scientific Title | Pre-procedure oral rabeprazole administration for the prevention of bleeding after endoscopic submucosal dissection for gastric neoplasms |
| Date of disclosure of the study information | 2013/08/14 |
| Last modified on | 2013/08/14 16:36:45 |
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Basic information
Public title
Pre-procedure oral rabeprazole administration for the prevention of bleeding after endoscopic submucosal dissection for gastric neoplasms
Acronym
Oral PPI for preventing ESD bleeding
Scientific Title
Pre-procedure oral rabeprazole administration for the prevention of bleeding after endoscopic submucosal dissection for gastric neoplasms
Scientific Title:Acronym
Oral PPI for preventing ESD bleeding
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate oral PPI administration effectiveness on the day of ESD to prevent post-ESD bleeding
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
post-ESD bleeding rate
Key secondary outcomes
change in gastric pH
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral PPI administration
Interventions/Control_2
endoscopic submucosal dissection
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The indication for gastric ESD was well or moderately differentiated adenocarcinoma of any size without ulceration or signs of submucosal invasion. Even if biopsy of the lesion led to a diagnosis of adenoma, it was determined that ESD was indicated when it met one of the following criteria: more than 2 cm diameter, reddish color, depressed lesion, and increasing size.
Key exclusion criteria
Patients were excluded if they had received acid-suppressive drugs up to one week before pre-ESD endoscopy or Helicobacter pylori (Hp) eradication, or if they had a history of gastrectomy, major organ failure, or a drug allergy for PPI
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Ohira |
Organization
Fukushima Medical University
Division name
Department of Gastroenterology and Rheumatology
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuto Hikichi |
Organization
Fukushima Medical University Hospital
Division name
Department of Endoscopy
Zip code
Address
TEL
Homepage URL
takuto@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
福島県立医科大学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 14 | 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
Completed
Date of protocol fixation
| 2007 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2007 | 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
| 2013 | Year | 08 | Month | 14 | Day |
Last modified on
| 2013 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013443
