UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Potential of Automatic Diagnosis System with Image Enhanced Endoscopy for Diagnosis of Helicobacter. Pylori Infection
Title of the study (Brief title)	AI with LCI for diagnose HP infection
Region	Japan

Condition
Condition	Chronic Gastritis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is necessary to establish universal methods for endoscopic diagnosis of Helicobacter pylori (HP) infection, such as a computer-aided diagnosis. In this study, we propose a multistage diagnosis algorithm for HP infection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The aims of this study are to construct a novel automatic diagnostic system for HP infection using a Support vector machine (SVM) .
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	we used five LCI images per case, which were taken from lesser curvature (angle-lower body and middle-upper body) and greater curvature (angle-lower body and middle-upper body) and fornix.
Key exclusion criteria	We excluded patients who were not checked H.p. infection by more than two examination or who have mucosal atrophy but did not have a history of H.p. eradication (thought to be spontaneous eradication) and who were not taken from all five view.
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuda Takeshi
Organization	Asahi University hospital
Division name	Gastroenterology
Address	3-23, Hashimoto-cho Gifu city
TEL	058-253-8001
Email	t-yasuda@koto.kpu-m.ac.jp

Public contact
Name of contact person	Yagi Nobuaki
Organization	Asahi University Hospital
Division name	Gastroenterology
Address	3-23, Hashimoto-cho Gifu city
TEL	058-253-8001
Homepage URL
Email	t-yasuda@koto.kpu-m.ac.jp

Sponsor
Institute	Asahi University Hospital department of Gastroenterology
Institute
Department

Funding Source
Organization	None.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2019 Year 03 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	We retrospectively analyzed patients who were checked H.p. infection by more than two different examinations and taken by LCI mode at Asahi University Hospital.were carried out using a LASEREO system (VP-4450 or -7000, and LL-4450 or -7000) and an upper gastrointestinal endoscope (EG-L590ZW or EG-L600ZW).

Management information
Registered date	2019 Year 03 Month 08 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041152