UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035887
Receipt number R000040890
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.
Date of disclosure of the study information 2019/02/15
Last modified on 2021/08/19 17:36:48

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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 or person

Institute

School of Medicine, Tottori University Faculty of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040890


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name