UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004724
Receipt number R000004455
Scientific Title Efficasy of steroid injection to artificial ulcer of endoscopic submucosal dissection and effect to regenerative mucosa
Date of disclosure of the study information 2010/12/14
Last modified on 2012/06/14 15:09:01

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Basic information

Public title

Efficasy of steroid injection to artificial ulcer of endoscopic submucosal dissection and effect to regenerative mucosa

Acronym

Gastric steroid injection

Scientific Title

Efficasy of steroid injection to artificial ulcer of endoscopic submucosal dissection and effect to regenerative mucosa

Scientific Title:Acronym

Gastric steroid injection

Region

Japan


Condition

Condition

Early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Effectiveness of regeneration of artificial post ESD ulcer by local injection of steroid

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression of regenerative mucosa of post ESD ulcer and reduction of deformity of post ESD stomach

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Local injection to post ESD ulcer

Interventions/Control_2


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

50 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients those who are undergone ESD

Key exclusion criteria

Patients those who have post ESD bleeding

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mori Hirohito

Organization

Kagawa University

Division name

Department of gastroenterology and Neurology

Zip code


Address

1750-1 Miki Kida Kagawa Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kagawa university

Division name

Gastroenterology and Neurology

Zip code


Address


TEL


Homepage URL


Email

hiro4884@med.kagawa-u.ac.jp


Sponsor or person

Institute

Kagawa university
Department of gastroenterology and Neurology

Institute

Department

Personal name



Funding Source

Organization

Kagawa university
Department of gastroenterology and Neurology

Organization

Division

Category of Funding Organization

Other

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

香川大学医学部付属病院


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 14 Day


Related information

URL releasing protocol


Publication of results

Published


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

2010 Year 06 Month 14 Day

Date of IRB


Anticipated trial start date

2010 Year 07 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 12 Month 14 Day

Last modified on

2012 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004455


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name