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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046113
Receipt No. R000052637
Scientific Title Clinical effect of intragastric air quantity on the endoscopic diagnostic ability for gastric cancer after Helicobacter pylori-eradication therapy
Date of disclosure of the study information 2021/11/18
Last modified on 2021/11/18

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Basic information
Public title Clinical effect of intragastric air quantity on the endoscopic diagnostic ability for gastric cancer after Helicobacter pylori-eradication therapy
Acronym intragastric air quantity
Scientific Title Clinical effect of intragastric air quantity on the endoscopic diagnostic ability for gastric cancer after Helicobacter pylori-eradication therapy
Scientific Title:Acronym intragastric air quantity
Region
Japan

Condition
Condition early gastric cancer after Helicobacter pylori-eradication therapy
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the effect of intragastric air quantity on endoscopic images in early gastric cancer after Helicobacter pylori-eradication therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visibility of demarcation line during insufflation and deaeration
Key secondary outcomes Effect of intragastric air quantity on the color tone of endoscopic images, correct diagnosis rate of endoscopic range diagnosis for gastric cancer after Helicobacter pylori-eradication therapy

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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 endoscopic observation and marking during gastric insufflation and degassing
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically diagnosed as differentiated gastric cancer.
2)Clinically stage IA is suspected.
3)The lesion has a tumor diameter of 2 cm or more, and the macroscopic type is 0-IIb or 0-IIc.
4)After H.pylori-eradication therapy.
5)Negative on two or more H. pylori infection tests (serum antibody, urea breath test, fecal antigen, etc.).
6)General status is expected to be tolerant of endoscopic exam and resection.
7)Prognosis is expected to be improved by endoscopic resection of the lesion.
8) The age at the time of consent is 20 years or older.6
9)Patient agree with the participation in the study.
Key exclusion criteria 1) Sufficient endoscopic observation is difficult.
2) Surgery was selected.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kotaro
Middle name
Last name Shibagaki
Organization Shimane University Hospital
Division name Endoscopy Unit
Zip code 6938501
Address 89-1 Enya, Izumo, Japan
TEL +81-85320-2190
Email kotaro@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Maki
Middle name
Last name Watanabe
Organization Shimane University Hospital
Division name Gastroenterology
Zip code 6938501
Address 89-1 Enya, Izumo, Japan
TEL +81-85320-2190
Homepage URL
Email maki-w@med.shimane-u.ac.jp

Sponsor
Institute Gastroenterology, Faculty of Medicine, Shimane University
Institute
Department

Funding Source
Organization No fund.
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 Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address 89-1 Enya, Izumo, Japan
Tel +81-85320-2515
Email kenkyu@med.shimane-u.ac.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

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 18 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 Open public recruiting
Date of protocol fixation
2020 Year 08 Month 06 Day
Date of IRB
2020 Year 09 Month 18 Day
Anticipated trial start date
2021 Year 06 Month 23 Day
Last follow-up date
2024 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 18 Day
Last modified on
2021 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052637

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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