UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063227 |
|---|---|
| Receipt number | R000072355 |
| Scientific Title | Computed tomography angiography-first versus immediate operation for penetrating neck injury patients with hard signs: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2026/10/09 |
| Last modified on | 2026/10/09 09:32:58 |
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Basic information
Public title
Computed tomography angiography for penetrating neck injury with hard signs: a systematic review and meta-analysis
Acronym
PNI-CTA SR/MA
Scientific Title
Computed tomography angiography-first versus immediate operation for penetrating neck injury patients with hard signs: a systematic review and meta-analysis
Scientific Title:Acronym
PNI-HS-CTA SR/MA
Region
| Japan |
Condition
Condition
Penetrating neck injury with hard signs
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To systematically evaluate whether a computed tomography angiography (CTA)-first strategy, compared with immediate operative exploration, is associated with improved clinical outcomes in adult patients with penetrating neck injury presenting with hard signs who are hemodynamically stable and, when necessary, have a secured airway.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of neck operation comparing a CTA-first strategy with immediate operative exploration. Dichotomous outcomes will be synthesized using pooled risk ratios with 95% confidence intervals.
Key secondary outcomes
1.Incidence of missed injury
2.Incidence of complications
3.Mortality
4.Blood transfusion volume
5.Intensive care unit length of stay
6.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
Studies meeting the following criteria will be included: adult patients with penetrating neck injury presenting with hard signs; patients who are hemodynamically stable or stabilized after initial resuscitation; studies evaluating a CTA-first strategy and/or immediate operative exploration; and studies reporting extractable data for at least one prespecified outcome.
Key exclusion criteria
Studies will be excluded if they include only pediatric patients; do not primarily evaluate penetrating neck injury; do not allow extraction of data for patients with hard signs; do not provide evaluable outcomes for CTA-first or immediate operative management; are case reports, reviews, or other non-primary studies; or lack extractable outcome data.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Akutsu |
Organization
Tsuchiura Kyodo General Hospital
Division name
Trauma and Acute Care Surgery
Zip code
3000028
Address
4-1-1 Otsuno Tsuchiura Ibaraki Japan
TEL
0298303711
doitin41@gmail.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Akutsu |
Organization
Tsuchiura Kyodo General Hospital
Division name
Trauma and Acute Care Surgery
Zip code
3000028
Address
4-1-1 Otsuno Tsuchiura Ibaraki Japan
TEL
09053225262
Homepage URL
doitin41@gmail.com
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
Tomohiro Akutsu
Funding Source
Organization
The Japanese Association for The Surgery of Trauma, the General Insurance Association of Japan and Zenkyoren(National Mutual Insurance Federation of Agricultural Cooperatives).
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
No
Address
No
Tel
No
No
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 | 10 | Month | 09 | 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
635
Results
CTA first significantly reduced neck operations versus immediate surgery (RR 0.07,95% CI 0.01-0.50), with no clear increase in complications (RR 0.88,95% CI 0.36-2.16), missed injuries, or mortality.
Results date posted
| 2026 | Year | 10 | Month | 09 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a systematic review and meta-analysis comparing a CTA-first strategy with immediate operative exploration in adult patients with penetrating neck injury presenting with hard signs. Relevant studies will be systematically identified using electronic databases. Study selection and data extraction will be performed independently by multiple reviewers according to prespecified eligibility criteria. The primary outcome is the rate of neck operation. Secondary outcomes include missed injury, complications, mortality, blood transfusion volume, ICU length of stay, and hospital length of stay. For dichotomous outcomes, risk ratios with 95% confidence intervals will be calculated and pooled when appropriate. Risk of bias will be assessed for included studies, and certainty of evidence will be evaluated using the GRADE approach.
Management information
Registered date
| 2026 | Year | 10 | Month | 09 | Day |
Last modified on
| 2026 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072355
