UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043417 |
|---|---|
| Receipt number | R000049573 |
| Scientific Title | Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT |
| Date of disclosure of the study information | 2021/02/22 |
| Last modified on | 2026/04/04 10:48:58 |
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Basic information
Public title
Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Acronym
Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Scientific Title
Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Scientific Title:Acronym
Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Region
| Japan |
Condition
Condition
right-side colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the peak of venous phase enhancement can be appropriately scanned by low dose monitoring for right-side colon cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CT value in venous phase
Key secondary outcomes
Timing of venous scan
CT value of parenchymal organs
Patient characteristics
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CT scanned with patient-specific timing
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
Patients who are performed 3D-CT for right-side colon cancer
Key exclusion criteria
Previous surgical history for gastroenterological diseases
Inappropriate for enrollment
Informed consent is not obtained
Iodine allergy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo
TEL
011-611-2111
itakemasa@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hamabe |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
ahamabe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Sapporo medical university hospital institutional review board
Address
291, South1 West16, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.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
| 2021 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0320630
Number of participants that the trial has enrolled
60
Results
CT values in the DBT group were significantly higher than those in the fixed-delay group. (portal vein: 266.7 HU vs. 210.0 HU; p < 0.001, gastrocolic trunk: 251.6 HU vs. 191.0 HU; p < 0.001, middle colic vein: 257.2 HU vs. 190.1 HU; p < 0.001). Visual assessment of the gastrocolic trunk was significantly higher in the DBT group than that in the fixed-delay group (DBT, 3.6, 3.4; fixed-delay, 2.6, 2.8; p = 0.003, p = 0.044).
Results date posted
| 2026 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Data from 30 consecutive patients who underwent CTC-A for right-sided colon cancer using the DBT method were prospectively collected and compared with that from 30 consecutive patients who underwent the conventional fixed-delay method between August 2018 and July 2022.
Participant flow
We prospectively collected data from 30 consecutive patients who underwent CTC-A with the DBT method for right-sided colon cancer at our institution between January 2020 and July 2022 and compared the data with the retrospectively collected data of 30 consecutive patients who underwent CTC-A using the conventional fixed-delay method from August 2018 to November 2019. Exclusion criteria were as follows: previous surgery for gastrointestinal disease, if the treating physician considered enrolment in this study inappropriate, history of severe side effects of contrast media, or if the patient could not consent to participate in the study.
Adverse events
Not applicable
Outcome measures
CT values of the portal vein, gastrocolic trunk, and middle colic veins were measured. Additionally, two gastrointestinal surgeons performed a five-point visual evaluation of the three-dimensional volume rendering image of the gastrocolic trunk.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049573
