UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007588
Receipt number R000008962
Scientific Title Effect of steroidmixed injection to submucosa during ESD on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage gastric cancer - Preventing stomach deformation due to scar formation during the epithelial regeneration process
Date of disclosure of the study information 2012/03/28
Last modified on 2012/03/28 00:05:26

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Basic information

Public title

Effect of steroidmixed injection to submucosa during ESD on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage gastric cancer
- Preventing stomach deformation due to scar formation during the epithelial regeneration process

Acronym

Kenacort for the stomach during ESD

Scientific Title

Effect of steroidmixed injection to submucosa during ESD on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage gastric cancer
- Preventing stomach deformation due to scar formation during the epithelial regeneration process

Scientific Title:Acronym

Kenacort for the stomach during ESD

Region

Japan


Condition

Condition

Early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A prospective study on preventing stomach deformation by injection of Kenacortmixed glycerin to submucosa during endoscopic submucosal dissection for gastric cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Area of gastric ulcer was measured by software.

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

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Add kenacort 80mg to epinephrine 1ample and indigocarmine 1ml, glycerine 40ml, hyaluronic acid 40ml and mix them up, inject them to submucosa during ESD.

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

30 years-old <=

Age-upper limit

95 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with early gastric cancer scheduled for endoscopic submucosal dissection from whom informed consent was obtained

Key exclusion criteria

Post operative stomach

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriko Nishiyama

Organization

Kagawa university

Division name

Department of gastroenterology

Zip code


Address

1750-1 ooaza ikenobe miki town kida county kagawa prefecture

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kagawa university

Division name

Department of gastroenterology

Zip code


Address


TEL

087-891-2156

Homepage URL


Email



Sponsor or person

Institute

Kagawa university

Institute

Department

Personal name



Funding Source

Organization

Kagawa university

Organization

Division

Category of Funding Organization

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

2012 Year 03 Month 28 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

Preinitiation

Date of protocol fixation

2012 Year 03 Month 27 Day

Date of IRB


Anticipated trial start date

2012 Year 03 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

2012 Year 03 Month 28 Day

Last modified on

2012 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008962


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name