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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004394
Receipt No. R000005253
Scientific Title Prospective study of efficacy of prophylactic hemostasis for ulceration post endoscopic submucosal dissection of early gastric tumor.
Date of disclosure of the study information 2010/10/16
Last modified on 2010/10/16

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Basic information
Public title Prospective study of efficacy of prophylactic hemostasis for ulceration post endoscopic submucosal dissection of early gastric tumor.
Acronym Efficacy of hemostasis post ESD.
Scientific Title Prospective study of efficacy of prophylactic hemostasis for ulceration post endoscopic submucosal dissection of early gastric tumor.
Scientific Title:Acronym Efficacy of hemostasis post ESD.
Region
Japan

Condition
Condition Early gastric cancer and adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim is this study is to evaluate the efficacy of prophylactic hemostasis post endoscopic submucosal dissection for early gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Retio of delayed bleeding(hematemesis or melena required endoscopic hemostasis, decreased the hemoglobin count by more than 2g/dl)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endoscopic submucosal dissection
Interventions/Control_2 coagulation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were diagnosed as early gastric cancer or gastric adenoma and are considered as the indication of endoscopic submucosal dissection.
Patients who understand the study contents and give informed consents by themselves
Key exclusion criteria 1.Patient with major organ failure(heart failure,renal failure,liver failure, Respiratory failure)
2, Patients who have anticoagulant or antiplatelet therapy and who cannot stop it.
3.Patient with Pacer planting
4. Patients who were judged inappropriate by their physicians.
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Machida Hirohisa
Organization Osaka City University Graduate School of Medicine, Osaka, Japan
Division name Department of Gastroenterology
Zip code
Address Asahimachi abenoku oosaka citu
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka City University Graduate School of Medicine, Osaka, Japan
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute School of Medicine, Osaka, Japan
Institute
Department

Funding Source
Organization School of Medicine, Osaka, Japan
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
2010 Year 10 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 No longer recruiting
Date of protocol fixation
2008 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 08 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 10 Month 16 Day
Last modified on
2010 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005253

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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