Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism - a Randomized, Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Jacob Kinggaard Lilja-Fischer, MD
jaclil@rm.dk
+4540460399
Backup
Lars Rolighed, MD, PhD
larsroli@rm.dk
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-01
Participants
Target number of participants: 160
Treatments
No_intervention: Control group
Patients randomized to the experimental group will have surgery performed in the exact same manner as in the control group.
Experimental: Surgery with EleVision IR camera system
In 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.
Related Therapeutic Areas
Sponsors
Leads: Aarhus University Hospital