UMIN-CTR Clinical Trial

Public title

examination of the Helicobacter pylori detection of the antigen kit among Helicobacter pylori services using irrigation water in the stomach in the endoscopy

Acronym

examination of the Helicobacter pylori detection of the antigen kit among Helicobacter pylori services using irrigation water in the stomach in the endoscopy

Scientific Title

examination of the Helicobacter pylori detection of the antigen kit among Helicobacter pylori services using irrigation water in the stomach in the endoscopy

Scientific Title:Acronym

examination of the Helicobacter pylori detection of the antigen kit among Helicobacter pylori services using irrigation water in the stomach in the endoscopy

Region

Japan

Condition

Helicobacter pylori gastritis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We determine the Helicobacter pylori detectability of the antigen kit of feces using irrigation water in the stomach in the endoscopy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Rate of agreement with "irrigation water in the stomach" in the antigen during the Helicobacter pylori service and "feces"

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

1)For the subject patient who came to the hospital, we acquire an agreement in a document about the participation in this study and register ourselves.
2)We carry out endoscopy upper gastrointestinal tract and make entry of endoscopic findings and degree of the mucosa atrophy, others need matter in a case report.
3)We collect irrigation water in the stomach at endoscopy and we use an antigen kit during the Helicobacter pylori service and judge it.
4)We collect feces and judge it using an antigen kit during the Helicobacter pylori service.
5)All results explain a test result in the foreign consultation of the patient after revelation.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)The patient who carried out an endoscopy
2)At the agreement acquisition age more than 20 years old
3)The patient that a document agreement was obtained about participation of this study

Key exclusion criteria

1)The patient who performed Helicobacter pylori sanitization treatment in the past
2)We are the patients within four weeks after during the sanitization medicine taking or taking end
3)We are the patients within two weeks after during the medicine (proton pump inhibitor) taking having bacteriostatic action or taking end
4)When a clear loss is found in a stomach
5)When a vomiting reflex in the endoscopy is strong
6)A case of Performance status 1-4
7)A case of ASA classification 3-
8)In addition, when doctor attending intended for it and admitted that we were inadequate

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Koichiro Kawano

Organization

Hyogo Prefectural Awaji medical center

Division name

Department of gastroenterology

Zip code

Address

1-1-137Shioya, Sumoto-city, Hyogo

TEL

0799-22-1200

Email

toranoana18@hotmail.com

Name of contact person

1st name
Middle name
Last name	Koichiro Kawano

Organization

Hyogo Prefectural Awaji medical center

Division name

Department of gastroenterology

Zip code

Address

1-1-137Shioya, Sumoto-city, Hyogo

TEL

0799-22-1200

Homepage URL

Email

toranoana18@hotmail.com

Institute

Hyogo Prefectural Awaji medical center

Institute

Department

Personal name

Organization

Wakamoto Pharmaceutical

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

11

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

06

Month

28

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

11

Day

Last modified on

2018

Year

10

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026417