Health TrialsbyHealthPanel

Autofluorescence in Surgery for Primary Hyperparathyroidism

ConditionHyperparathyroidism, Primary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital

About this trial

The study aims to test if autofluorescence imaging (AF) is a useful surgical aid during parathyroidectomy (PTX) for primary hyperthyroidism (PHPT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age>18 years and able to give informed consent.

A diagnosis of PHPT.

Planned exploratory PTX with ioPTH measurement.

Disqualifiers

Concordant high-confidence imaging; planned focused/selective PTX

Previous thyroid or parathyroid surgery.

Planned simultaneous thyroid surgery.

MEN, lithium induced hyperparathyroidism.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgery with autofluorescence

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Surgery with EleVision IR camera systemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Operating time

Time elapsed from skin incision to skin closure in patients who achieve normocalcemia after one operation.

Time frame
During surgery

Secondary outcomes

1

Normocalcemia

Proportion of patients with normocalcemia after 2 months after only one surgical procedure without treatment with active vitamin D or \>1g calcium daily.

Time frame
2 months
2

Extent of surgery

Proportion of patients having thyroidectomy or thymectomy to eradicate parathyroid tissue

Time frame
During surgery
3

Number of ioPTH measurements

Number of ioPTH measurements

Time frame
During surgery
4

ioPTH reduction

Relative PTH reduction (first to last measurement).

Time frame
During surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aarhus University Hospital

Lead sponsor

Source ClinicalTrials.gov
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