UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study on the relation between the detection of chest/abdominal wall vein and liver reserve or esophageal varices using cellphone application Vein Seek.
Acronym	An exploratory study on the detection of chest/abdominal wall vein.
Scientific Title	An exploratory study on the relation between the detection of chest/abdominal wall vein and liver reserve or esophageal varices using cellphone application Vein Seek.
Scientific Title:Acronym	An exploratory study on the detection of chest/abdominal wall vein.
Region	Japan

Condition
Condition	chronic liver disease, liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to evaluate the degree of the abdominal wall vein of patients with liver cirrhosis by using the application for blood vessel image enhancement and analyze its clinical meaning.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ability of Vein Seek on detecting chest wall and abdominal wall vein of cirrhotic patients.
Key secondary outcomes	1) Correlation with hepatic reserve (Child-Pugh classification) 2) Correlation with clinical images (endoscopic examination, CT images, MRI images)

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients, regardless of hospitalization or outpatient, who meet either of the following criteria are targeted. 1) Subjects who are clinically suspected of chronic liver disease; it is selected to investigate from which stage of liver disease chest wall / abdominal wall vein can be detected. 2) Subjects who have already been confirmed to have cirrhosis.
Key exclusion criteria	Patients who conflict with the following will not be included in this clinical study. 1) Subjects who have skin lesions and are difficult to acquire images. 2) Subjects who the researcher judged unsuitable for this study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takaaki Middle name Last name Sugihara
Organization	Tottori University Hospital
Division name	Department of Gastroenterology
Zip code	6838504
Address	36-1, Nishi-cho, Yonago city, Tottori prefecture, Japan, 683-8504,
TEL	0859386527
Email	sugitaka@tottori-u.ac.jp

Public contact
Name of contact person	1st name Takaaki Middle name Last name Sugihara
Organization	Tottori University Hospital
Division name	Department of Gastroenterology
Zip code	6838504
Address	36-1, Nishi-cho, Yonago city, Tottori prefecture, Japan, 683-8504,
TEL	0859386527
Homepage URL
Email	sugitaka@tottori-u.ac.jp

Sponsor
Institute	School of Medicine, Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization	School of Medicine, Tottori University Faculty of Medicine
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	Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital
Address	36-1, Nishi-cho, Yonago city, Tottori prefecture, Japan, 683-8504,
Tel	0859387108
Email	me-rinshoukenkyu@ml.adm.tottori-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	2019 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://bmcmedimaging.biomedcentral.com/articles/10.1186/s12880-021-00655-8
Number of participants that the trial has enrolled	100
Results	Vein-weighted images (VWI) could significantly visualize abdominal wall variecs (AWV) than unmanipulated images (UI) (72% vs 24%, p =0.0005). Multivariate analysis demonstrated that VWI-AWV grade 2 was an independent factor related to the presence of non-treated GOV [OR=3.05 (1.24-7.53), p=0.016]. The vein-viewing application non-invasively detected AWV related to the presence of cirrhosis and GOV, and VWI-AWV grade 2 was an independent factor related to the presence of non-treated GOV.
Results date posted	2021 Year 08 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 08 Month 12 Day
Baseline Characteristics	One hundred patients with chronic liver diseases were prospectively enrolled. All the patients underwent esophagogastroduodenoscopy within three months of the enrollment. The causes of liver diseases among the 71 men and 29 women (median age, 70.5 yr) included Hepatitis B (n=19), Hepatitis C (n=21), alcoholism (n=33), primary biliary cholangitis (n=3), autoimmune hepatitis (n=4) and others (n=20).
Participant flow
Adverse events	none
Outcome measures	Unmanipulated images (UI) and vein-weighted images (VWI) were taken for assessing AWV by a vein-viewing application on iPhone. Two doctors independently evaluated both image types. We defined the grading of both UI and AWV as grade 0 (non-detectable), grade 1 (slightly detectable), and grade 2 (distinct)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 12 Month 22 Day
Date of IRB	2018 Year 12 Month 07 Day
Anticipated trial start date	2018 Year 12 Month 22 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry	2020 Year 08 Month 31 Day
Date trial data considered complete	2020 Year 08 Month 31 Day
Date analysis concluded	2020 Year 09 Month 30 Day

Other
Other related information	none

Management information
Registered date	2019 Year 02 Month 15 Day
Last modified on	2021 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040890