Use of Intraoperative Autofluorescence Imaging in Surgery for Primary Hyperparathyroidism - 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 autofluorescence imaging (AF) is a useful surgical aid during parathyroidectomy (PTX) for primary hyperthyroidism (PHPT).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age\>18 years and able to give informed consent.
• A diagnosis of PHPT.
• Planned exploratory PTX with ioPTH measurement.
Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Jacob K 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: 2026-06-01
Participants
Target number of participants: 100
Treatments
No_intervention: Control group
Patients will be operated with a standard exploratory PTX, with visual identification of PTGs. Unilateral or bilateral parathyroid exploration will be determined by the surgeon, depending on preoperative imaging and intraoperative findings. Usually, the procedure will be terminated when intraoperative parathyroid hormone (PTH) measurement shows a \>50% decline, after removal of suspected pathological PTGs.
Experimental: Surgery with EleVision IR camera system
Patients randomized to the experimental group will have surgery performed in the exact same manner as in the control group.~In the experimental group, the surgeon will use the EleVision IR camera system (Medtronic, USA) to visualize PTGs during surgery. The surgical field will be visualized with AF as a minimum of two times during surgery on each side of the neck: First upon exposing the undersurface of the thyroid gland, and secondly before removal of a pathological PTG. Also, removed PTGs will be examined ex vivo to document AF pattern.
Related Therapeutic Areas
Sponsors
Leads: Aarhus University Hospital