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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001978
Receipt No. R000002330
Scientific Title comparison between endoscopic clipping and combination of endoscopic clipping and injection for gastric ulcer bleeding: a prospective randomized controlled trial
Date of disclosure of the study information 2009/05/16
Last modified on 2015/06/26

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Basic information
Public title comparison between endoscopic clipping and combination of endoscopic clipping and injection for gastric ulcer bleeding: a prospective randomized controlled trial
Acronym comparison between endoscopic clipping and combination of endoscopic clipping and injection for gastric ulcer bleeding: a prospective randomized controlled trial
Scientific Title comparison between endoscopic clipping and combination of endoscopic clipping and injection for gastric ulcer bleeding: a prospective randomized controlled trial
Scientific Title:Acronym comparison between endoscopic clipping and combination of endoscopic clipping and injection for gastric ulcer bleeding: a prospective randomized controlled trial
Region
Japan

Condition
Condition gastric ulcer bleeding
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 comparison between endoscopic clipping and combination therapy for gastric ulcer bleeding
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes temporary hemostasis, rebleeding rate, permanent hemostasis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 endoscopic hemoclipping for gastric ulcer bleeding
Interventions/Control_2 endoscopic hemoclipping with epinephrine injection for gastric ulcer bleeding
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 Patients with gastric ulcer bleeding who are considered as the indication of endoscopic hemostasis
Key exclusion criteria Patients with upper gastrointestinal bleeding except for gastric ulcer
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Imaeda, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email imaedahi@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Imaeda, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email imaedahi@yahoo.co.jp

Sponsor
Institute Division of Gastroenterology,Department of Internal Medicine, Keio University
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 16 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
2009 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2012 Year 04 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
2009 Year 05 Month 16 Day
Last modified on
2015 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002330

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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