UMIN-CTR Clinical Trial

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