UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026391
Receipt number R000030325
Scientific Title Short-term ulcer healing induced by P-CAB following gastric endoscopic submucosal dissection:a propensity score analysis
Date of disclosure of the study information 2017/03/03
Last modified on 2018/09/11 17:35:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Short-term ulcer healing induced by P-CAB following gastric endoscopic submucosal dissection:a propensity score analysis

Acronym

Short-term ulcer healing induced by P-CAB following gastric endoscopic submucosal dissection

Scientific Title

Short-term ulcer healing induced by P-CAB following gastric endoscopic submucosal dissection:a propensity score analysis

Scientific Title:Acronym

Short-term ulcer healing induced by P-CAB following gastric endoscopic submucosal dissection

Region

Japan


Condition

Condition

early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

clarify the effect of vonoprazan on promoting ESD-related ulcer healing compared with lansoprazole for 14 days

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the ulcer reduction ratio 14 days after ESD

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

the gastric cancers adhering to the expanded criteria

Key exclusion criteria

a history of prior surgery,
lesions with scars),
lesions with a steroid injection,
postoperative bleeding,
an additional surgery,
lost to follow-up

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yohei Horikawa

Organization

Hiraka General Hospital

Division name

Gastroenterology

Zip code


Address

Maego, Yatsukuchi, 3-1, Yokote city

TEL

0182-32-5121

Email

horikawa_01@me.com


Public contact

Name of contact person

1st name
Middle name
Last name Yohei Horikawa

Organization

Hiraka General Hospital

Division name

Gastroenterology

Zip code


Address

Maego, Yatsukuchi, 3-1, Yokote city

TEL

0182-32-5121

Homepage URL


Email

horikawa_01@me.com


Sponsor or person

Institute

Hiraka General Hospital

Institute

Department

Personal name



Funding Source

Organization

no

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



Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 03 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

2017 Year 03 Month 03 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2017 Year 10 Month 01 Day

Date of closure to data entry

2017 Year 10 Month 01 Day

Date trial data considered complete

2017 Year 10 Month 01 Day

Date analysis concluded

2017 Year 10 Month 01 Day


Other

Other related information

nothing


Management information

Registered date

2017 Year 03 Month 03 Day

Last modified on

2018 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030325


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name