UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005589
Receipt number R000006579
Scientific Title Effect of genotyping of P450 CYP2C19 and PPI on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage gastric cancer.
Date of disclosure of the study information 2011/05/11
Last modified on 2022/11/18 10:30:34

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Basic information

Public title

Effect of genotyping of P450 CYP2C19 and PPI on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage gastric cancer.

Acronym

Genotyping of P450 CYP2C19 and PPI for artificial ulcer following ESD

Scientific Title

Effect of genotyping of P450 CYP2C19 and PPI on the epithelial regeneration promoting action of postoperative artificial ulcer following endoscopic submucosal dissection in early-stage gastric cancer.

Scientific Title:Acronym

Genotyping of P450 CYP2C19 and PPI for artificial ulcer following ESD

Region

Japan


Condition

Condition

Early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A retrospective study about effect on reparing ,regeneration and prevention stomach deformation accoding to genotyping of P450 CYP2C19 with LPZ or RPZ following endoscopic submucosal dissection in early-stage gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Distance between marking clips placed on either side of the ulcer in the direction of short axis and length of the short axis

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

Interventions/Control_1

In the LPZ group, intravenous drip infusion of LPZ(morinign/night 30mg each) for 2days after ESD,and taking 2tablets of LPZ from 3days after ESD.
In the RPZ group, intravenous drip infusion of RPZ(morinign/night 30mg each) for 2days after ESD,and taking 2tablets of RPZ from 3days after 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 wuth early gastric cancer scheduled for endoscopic submucosal dissection from whom informed consent was oobtained

Key exclusion criteria

Post operative stomach

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name nishiyama noriko ,mori hirohito

Organization

Kagawa university

Division name

Department of gastroenterology and neurology

Zip code


Address

1750-1 ooaza ikenobe miki town kida country kagawa prefecture

TEL

0878912156

Email

n-nori@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name nishiyama noriko

Organization

Kagawa university

Division name

Department of gastroenterology and neurology

Zip code


Address

1750-1 Miki, Kita, Kagawa 761-0793

TEL

0878912156

Homepage URL


Email

n-nori@med.kagawa-u.ac.jp


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

2011 Year 05 Month 11 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

2011 Year 05 Month 02 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2014 Year 03 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

2011 Year 05 Month 11 Day

Last modified on

2022 Year 11 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006579


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name