UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044231 |
|---|---|
| Receipt number | R000050515 |
| Scientific Title | A prospective observational study on the usefulness of dynamic digital radiography for the evaluation of vocal cold paralysis after cervical surgery |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2025/11/21 19:46:13 |
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Basic information
Public title
A prospective observational study on the usefulness of dynamic digital radiography for the evaluation of vocal cold paralysis after cervical surgery
Acronym
A prospective observational study on the usefulness of dynamic digital radiography for the evaluation of vocal cold paralysis after cervical surgery
Scientific Title
A prospective observational study on the usefulness of dynamic digital radiography for the evaluation of vocal cold paralysis after cervical surgery
Scientific Title:Acronym
A prospective observational study on the usefulness of dynamic digital radiography for the evaluation of vocal cold paralysis after cervical surgery
Region
| Japan |
Condition
Condition
Thyroid tumor, Parathyroid tumor
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the findings of dynamic digital radiography for postoperative vocal cold paralysis.
To establish the dynamic evaluation index effective for the detection of postoperative vocal cold paralysis.
Basic objectives2
Others
Basic objectives -Others
To clarify the correlation between the dynamic digital radiography and standard tests such as laryngoscopy for evaluation of vocal cold paralysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative findings of vocal cord movements visible on the dynamic digital radiography.
Quantitative index that characterizes bilateral and unilateral vocal cord movements obtained from analyzing dynamic digital radiography.
Key secondary outcomes
To evaluate the consistency of quantitative findings on dynamic digital radiography and laryngoscopy.
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
Patients scheduled for surgery for a tumor of the thyroid or parathyroid gland who understand the purpose of this study with written informed consent.
Key exclusion criteria
1) Patients for whom moving to the imaging room is physically burdened
2) Patients with pacemakers inserted
3) Patients who are pregnant or breastfeeding
4) Patients who require urgent treatment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yukimi |
| Middle name | |
| Last name | Shibuya |
Organization
Kyorin University
Division name
Thoracic and Thyroid Surgery
Zip code
1810004
Address
Kyorin University
TEL
+81-0422-47-5511
yukimi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukimi |
| Middle name | |
| Last name | Shibuya |
Organization
Kyorin University
Division name
Thoracic and Thyroid Surgery
Zip code
1810004
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL
+81-0422-47-5511
Homepage URL
yukimi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Konica Minolta
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University ethics committee
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
Tel
+81-0422-47-5511
rec@ks.kyorin-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
| 2021 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://doi.org/10.1002/hed.27756
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/hed.27756
Number of participants that the trial has enrolled
78
Results
Among the 70 enrolled patients, postoperative vocal cord paralysis (VCP) occurred in 12 (17.1%).
Qualitative diagnosis by DDR: sensitivity 67%, specificity 100%. Quantitative indices of DDR (vocal cord motion, VCM): non-VCP 4.4 mm, VCP 0.3 mm
Of the 12 VCP cases, 9 recovered within 12 months, while 3 cases (4.3% of all patients) had persistent paralysis.
Results date posted
| 2025 | Year | 11 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
78 consecutive patients who were scheduled to undergo surgery to treat neck tumors between June 2021 and December 2022.
Participant flow
All participants underwent FL, DDR, and maximum phonation time (MPT) measurements on the same day preoperatively and 2 to 5days postoperatively. Additionally, a symptom confirmation template was used to confirm the following subjective symptoms on Days 1 to 4 after surgery.
Adverse events
Nothing.
Outcome measures
1. Diagnostic performance of DDR for postoperative VCP
2. Preoperative and postoperative changes in VCM and MPT
3. ROC analysis of VCP diagnosis using VCM
4. Predictive value of VCM for VCP recovery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measuring the amount of vocal cold movements on each side.
Management information
Registered date
| 2021 | Year | 05 | Month | 17 | Day |
Last modified on
| 2025 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050515
