UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054327 |
|---|---|
| Receipt number | R000062063 |
| Scientific Title | Observational Study on Patch-Based Respiratory Phase Matching Method for Digital Subtraction Angiography under Spontaneous Respiration |
| Date of disclosure of the study information | 2024/05/07 |
| Last modified on | 2025/06/02 21:20:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational Study on Patch-Based Respiratory Phase Matching Method for Digital Subtraction Angiography under Spontaneous Respiration
Acronym
Observational Study on Patch-Based Respiratory Phase Matching Method for Digital Subtraction Angiography under Spontaneous Respiration
Scientific Title
Observational Study on Patch-Based Respiratory Phase Matching Method for Digital Subtraction Angiography under Spontaneous Respiration
Scientific Title:Acronym
Observational Study on Patch-Based Respiratory Phase Matching Method for Digital Subtraction Angiography under Spontaneous Respiration
Region
| Japan |
Condition
Condition
Patients with hepatocellular carcinoma, cirrhosis, portal hypertension
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to demonstrate whether a digital subtraction angiographic image with effectively suppressed artifacts can be obtained by employing a different subtraction method than conventional methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness of artifact reduction compared to conventional DSA images (5-point scale)
The evaluation will be carried out by two doctors with either gastroenterology, hepatology, or radiology expertise.
The reduction effect will be evaluated on a three-point scale based on whether the contrast effect of the following structures can be visually confirmed for both the conventional method and the test method, and the total score will be calculated.
(1)Angiography during TACE treatment
Tumor contrast effect 0,Insufficient (unknown structure) 1,Standard (unclear structure) 2,Sufficient (clear structure)
Hepatic artery contrast effect 0: Up to 1st branch 1: Up to 2nd branch 2: Up to 3rd branch
Diaphragm artifact 0,Present 1,Partially present 2,Absent
Intestinal gas artifact 0,Present 1,Partially present 2,Absent
(2)Angiography during hepatic venography
Hepatic vein contrast effect 0,Up to 1st branch 1,Up to 2nd branch 2,Up to 3rd branch
Diaphragm artifact 0,Present 1,Partially present 2,Absent
Intestinal gas artifact 0,Present 1,Partially present 2,Absent
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with hepatocellular carcinoma or with conditions of cirrhosis or portal hypertension
2) Patients who have undergone TACE between July 1, 2022 and December 31, 2024, and for whom moving images are stored
3) Patients who have undergone hepatic venography between July 1, 2022 and December 31, 2024, and for whom moving images are stored.
Key exclusion criteria
1) With unclear images
2) Those with missing values
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Nakamoto |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2648677
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
TEL
43222717
nakamotoer@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Fujimoto |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
TEL
43222717
Homepage URL
fujimoto.kentarou@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Chiba University Hospital
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
Tel
43222717
fujimoto.kentarou@chiba-u.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
| 2024 | Year | 05 | Month | 07 | 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
| 2023 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2024 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062063
