Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism
ConditionThyroid Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Planned simultaneous parathyroid surgery.
Treatment with active vitamin D analogues.
eGFR < 30.
Trial design
Design model
Parallel
Treatments tested in this trial
Surgery with autofluorescence
Procedure/SurgeryIn the experimental group, the surgeon will use the EleVision IR camera system (Medtronic, USA) to visualize parathyroid glands during surgery.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Surgery with EleVision IR camera systemExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 and 12 monthsSecondary outcomes
1
Permanent hypoparathyroidism
Proportion of patients who develop permanent hypoPT.
Time frame
6 and 12 months2
Intra-operative reduction in plasma concentration of PTH.
PTH is measured before start and immediately after surgery.
Time frame
During surgery3
Time to resolution of transient hypoPT.
Time to resolution of transient hypoPT.
Time frame
12 months4
Number of days hospitalized
Number of days hospitalized during first 30 days after surgery.
Time frame
30 daysOther outcomes
1
Histology report
Number of parathyroid glands (PGs) and lymph node metastases identified.
Time frame
1 week2
Extent of surgery
Central neck dissection, lateral neck dissection, autotransplantation of PGs.
Time frame
During surgery3
Complications
Bleeding, infection, recurrent nerve palsy, serious adverse events.
Time frame
30 days4
AF pattern
Description of AF pattern of tissue during central neck dissection / exploration, specifically with regards to lymph nodes, lymph node metastases and PGs.
Time frame
During surgerySponsors and contacts
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Source ClinicalTrials.gov