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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011487
Receipt No. 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

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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
Email

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
Email takuto@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013443

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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