UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060390 |
|---|---|
| Receipt number | R000065687 |
| Scientific Title | A systematic review of the efficacy of interventional radiology for adult abdominal organ injury with hemodynamic instability |
| Date of disclosure of the study information | 2026/01/17 |
| Last modified on | 2026/01/17 20:47:14 |
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Basic information
Public title
A systematic review of the efficacy of interventional radiology for adult abdominal organ injury with hemodynamic instability
Acronym
The efficacy of interventional radiology for adult abdominal organ injury with hemodynamic instability
Scientific Title
A systematic review of the efficacy of interventional radiology for adult abdominal organ injury with hemodynamic instability
Scientific Title:Acronym
The efficacy of interventional radiology for adult abdominal organ injury with hemodynamic instability
Region
| Japan |
Condition
Condition
trauma
Classification by specialty
| Surgery in general | Radiology | Operative medicine |
| Emergency medicine | Blood transfusion | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Open laparotomy for hemostasis is recommended by various guidelines for adult patients with hemodynamically unstable blunt abdominal solid organ injuries. However, several reports have suggested that even in hemodynamically unstable cases, hemostasis using interventional radiology (IVR) may allow for nonoperative management. In Japan, the availability of surgical and IVR treatment varies among institutions, and in some centers, IVR is selected even for hemodynamically unstable patients. When feasible, nonoperative management using IVR offers the advantage of reducing invasiveness to patients, but inappropriate selection of IVR in patients who actually require surgery may worsen outcomes. In Japan, whether IVR can be recommended on an equal footing with open laparotomy for adult patients with hemodynamically unstable blunt abdominal solid organ injuries remains under debate, and we have identified this issue as a key clinical question.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality (30-day, in-hospital)
Key secondary outcomes
Conversion to surgery, complication, time to definitive hemostasis, quantity of transfusion, hospital length of stay
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hemodynamically unstable blunt abdominal solid organ injuries
Key exclusion criteria
Conservative treatment without IVR or surgery
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Aoki |
Organization
National Defense Medical College Research Institute
Division name
Division of Traumatology
Zip code
3598513
Address
3-2, Namiki, Tokorozawa, Saitama
TEL
0429951633
aokimakoto@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Aoki |
Organization
National Defense Medical College Research Institute
Division name
Division of Traumatology
Zip code
3598513
Address
3-2 Namiki Tokorozawa
TEL
0429951633
Homepage URL
aokimakoto@ndmc.ac.jp
Sponsor or person
Institute
Japanese Association for the Surgery of Trauma
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for the Surgery of Trauma
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College Research Institute
Address
3-2 Namiki Tokorozawa
Tel
0429951633
aokimakoto@ndmc.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
| 2026 | Year | 01 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Japanese Association for the Surgery of Trauma Guideline, Systematic Review and Meta Analysis
Management information
Registered date
| 2026 | Year | 01 | Month | 17 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065687
