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
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
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
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
