UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021040
Receipt number R000024232
Scientific Title An acetic acid-indigocarmine mixture for the detection of early gastric cancers
Date of disclosure of the study information 2016/02/15
Last modified on 2020/06/02 13:02:41

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Basic information

Public title

An acetic acid-indigocarmine mixture for the detection of early gastric cancers

Acronym

An acetic acid-indigocarmine mixture for the detection of early gastric cancers

Scientific Title

An acetic acid-indigocarmine mixture for the detection of early gastric cancers

Scientific Title:Acronym

An acetic acid-indigocarmine mixture for the detection of early gastric cancers

Region

Japan


Condition

Condition

Patients examined by esophagogastroduodenoscopy

Classification by specialty

Gastroenterology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility of an acetic acid-indigocarmine mixture for the detection of early gastric cancers

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The rate of detection of early gastric cancers in according to pathological diagnosis ater 7 days of esophagogastroduodenoscopy and biopsy.

Key secondary outcomes

To evaluate these factors: age, smoking, mucosal atrophy, H. pylori infection, therapic history including endoscopic resection and gastrectomy of gastric cancer, tumor location and time of exmaination related to the detection of early gastric cancers by using an acetic acid-indigocarmine mixture


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

After conventional esopgagogastroduodenoscopy, an acetic acid-indigocarmine mixture (1.5% acetic acid, 0.4% indigocarmine and a small amount of dimethicone) was sprinkled onto the gastric mucosa.
Biopsy was taken from the unstained area and pathological diagnosis was examined.

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

Patients evaluated by esophagogastroduodenoscopy. Patients with written and oral informed consent are included.

Key exclusion criteria

Patients with severe complications are excluded.

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name Masashi
Middle name
Last name Hattori

Organization

Medical coroporation Yamashita Hospital

Division name

Gastroenterology

Zip code

4918531

Address

1-3-5, Nakamachi Ichnimomiya

TEL

0586-45-4511

Email

m.hattori@yamashita.or.jp


Public contact

Name of contact person

1st name Ippei
Middle name
Last name Matsuzaki

Organization

Medical coroporation Yamashita Hospital

Division name

Gastroenterology

Zip code

4918531

Address

1-3-5, Nakamachi Ichnimomiya

TEL

0586-45-4511

Homepage URL


Email

imatsu@med.nagoya-u.ac.jp


Sponsor or person

Institute

Medical coroporation Yamashita Hospital

Institute

Department

Personal name



Funding Source

Organization

Medical coroporation Yamashita Hospital

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

Medical coroporation Yamashita Hospital

Address

1-3-5, Nakamachi Ichnimomiya

Tel

0586-45-4511

Email

y.okudaira@yamashita.or.jp


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

医療法人 山下病院
Medical coroporation Yamashita Hospital


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 15 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

Completed

Date of protocol fixation

2016 Year 02 Month 12 Day

Date of IRB

2016 Year 01 Month 28 Day

Anticipated trial start date

2016 Year 02 Month 15 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 04 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 15 Day

Last modified on

2020 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024232


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name