Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism
1 other identifier
interventional
160
1 country
1
Brief Summary
The study aims to test if use of autofluorescence imaging (AF) reduces the risk of developing hypoparathyroidism (hypoPT) following surgery for thyroid cancer, either total thyroidectomy (TT) or completion hemithyroidectomy (cHT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
January 4, 2024
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
October 6, 2025
October 1, 2025
3 years
January 4, 2024
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypoparathyroidism
Proportion of patients who develop transient or permanent hypoPT requiring medical treatment with active vitamin D. HypoPT is diagnosed and treated according to protocol.
6 and 12 months
Secondary Outcomes (5)
Permanent hypoparathyroidism
6 and 12 months
Intra-operative reduction in plasma concentration of PTH.
During surgery
Time to resolution of transient hypoPT.
12 months
Number of days hospitalized
30 days
Oncological and composite outcomes
2 years
Other Outcomes (5)
Histology report
1 week
Extent of surgery
During surgery
Complications
30 days
- +2 more other outcomes
Study Arms (2)
Control group
NO INTERVENTIONPatients randomized to the experimental group will have surgery performed in the exact same manner as in the control group.
Surgery with EleVision IR camera system
EXPERIMENTALIn the experimental group, the surgeon will use the EleVision IR camera system (Medtronic, USA) to visualize PGs during surgery. The surgeon will use AF at minimum two timepoints on each side of the neck: First, when the thyroid lobe is exposed and mobilized, and secondly after removal of the thyroid lobe. This is repeated in the contralateral side of the neck in case of TT. If a central neck dissection is performed, the specimen is also examined with AF following removal. Autotransplantation of inadvertently removed PGs may be performed after frozen section histology.
Interventions
In the experimental group, the surgeon will use the EleVision IR camera system (Medtronic, USA) to visualize parathyroid glands during surgery.
Eligibility Criteria
You may qualify if:
- Age\>18 years and able to give informed consent.
- Suspicion or diagnosis of thyroid cancer.
- Planned total thyroidectomy or completion thyroidectomy.
- Normocalcemia prior to surgery.
You may not qualify if:
- Planned simultaneous parathyroid surgery.
- Treatment with active vitamin D analogues.
- eGFR \< 30.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, Denmark, 8200, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 4, 2024
First Posted
January 25, 2024
Study Start
January 1, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
October 6, 2025
Record last verified: 2025-10