UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052850 |
|---|---|
| Receipt number | R000060313 |
| Scientific Title | Intraoperative near-infrared autofluorescence imaging for transient and persistent hypocalcemia risk reduction after total thyroidectomy: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/11/21 |
| Last modified on | 2024/07/17 14:04:51 |
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Basic information
Public title
Intraoperative near-infrared autofluorescence imaging for transient and persistent hypocalcemia risk reduction after total thyroidectomy: A systematic review and meta-analysis
Acronym
Intraoperative near-infrared autofluorescence imaging for transient and persistent hypocalcemia risk reduction after total thyroidectomy: A systematic review and meta-analysis
Scientific Title
Intraoperative near-infrared autofluorescence imaging for transient and persistent hypocalcemia risk reduction after total thyroidectomy: A systematic review and meta-analysis
Scientific Title:Acronym
Intraoperative near-infrared autofluorescence imaging for transient and persistent hypocalcemia risk reduction after total thyroidectomy: A systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Thyroid disease requiring total thyroidectomy
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of intraoperative parathyroid autofluorescence observation on transient and persistent postoperative hypoparathyroidism in patients undergoing total thyroidectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of patients who developed hypocalcemia immediately after surgery and after long-term postoperative course
Key secondary outcomes
Number of parathyroid glands discovered during surgery, number of parathyroid autotransplantation, number of parathyroid glands accidentally removed, number of patients with hypoparathyroidism immediately after surgery and after long-term follow-up.
A meta-analysis was performed using the incidence of temporary/permanent-hypocalcemia/parathyroidism was compared between the groups using nearinfrared autofluorescense techniques and the naked-eye to identify parathyroid glands.
Meta-regression analyses were performed for each outcome to identify the moderators that influenced the pooled estimates of the meta-analyses. These moderators were: 1) disease type (malignant or benign), assessed by the rate of malignant disease; and 2) surgeon skill, assessed by the incidence of temporary hypocalcemia relying on the naked-eye.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinical studies are included if they meet the following criteria: (a) studies that included patients with thyroid disease (benign or malig- nant) who underwent total thyroidectomy; (b) studies that compared postoperative parathyroid function between Near-infrared imaging techniques and conventional surgery; and (c) studies that evaluated postoperative calcium and/or parathyroid hormone levels and the rate of hypocalcemia and/or hypoparathyroidism.
Key exclusion criteria
We exclude clinical studies that meet the following exclusion criteria: (a) those that included patients who underwent hemithyroidectomy, lobectomy, or partial thyroidectomy with or without central compartment neck dissection; (b) those in which other optical techniques (such as indocyanine green and methylene blue) were used for parathyroid gland protection during surgical procedure; (c) those that included patients with preoperative parathyroid gland disease and/or abnormal parathyroid function; and (d) reviews, meta-analyses, case reports, and animal experiments or basic research.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Takahashi |
Organization
Niigata University Faculty of Medicine
Division name
Department of Otolaryngology Head and Neck Surgery
Zip code
951-8510
Address
Asahimachi-dori 1, Chuo-ku, Niigata
TEL
+81-25-227-2306
takeshi-takahashi@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Takahashi |
Organization
Niigata University Faculty of Medicine
Division name
Department of Otolaryngology Head and Neck Surgery
Zip code
951-8510
Address
Asahimachi-dori 1, Chuo-ku, Niigata
TEL
+81-25-227-2306
Homepage URL
takeshi-takahashi@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Faculty of Medicine
Department of Otolaryngology Head and Neck Surgery
Takeshi Takahashi
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
Not applicable.
Address
Not applicable.
Tel
Not applicable.
Not applicable.
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
| 2023 | Year | 11 | Month | 21 | 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
| 2023 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After searching PubMed and web of science, the data has been adopted.
Management information
Registered date
| 2023 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060313
