UMIN-CTR Clinical Trial

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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