Hypocalcemia, Hypoparathyroidism Postprocedural, Surgery--Complications
Conditions
Keywords
thyroide surgery, total thyroidectomy, compltion thyroidectomy, parathyroidectomy, autofluorescense, NIR, near-infrared, optical imaging
Brief summary
The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.
Detailed description
Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to: 1. Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence. 2. Control: Conventional thyroidectomy and parathyroid identification by the surgeon. Measurements: PTH and ionized-Ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up. Anticipated 214 patients are included, all of which participate in 3 months follow-up. Only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up. An interim analysis will be conducted when inclusion of anticipated 128 patients and 3 months follow-up is reached.
Interventions
DEVICENIR optical imaging camera
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense
Sponsors
Cluster for molecular imaging, Denmark
Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand patient information and to give written informed consent * Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.
Exclusion criteria
* Not able to understand patient information and to give written informed consent * Previous parathyroid surgery or other parathyroid decease * Age under 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hypoparathyroidism | 24 months-follow-up | Hypoparathyroidism defined as: PTH \< 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hypocalcemia | 12 months follow-up | Hypocalcemia defined as: ionized Calcium \< 1,15 mmol/L |
| Time | Immediately after surgery | Duration of surgery |
| Parathyroidglands identified by NIR light | During surgery | Number of identified by NIR light vs. white light |
Countries
Denmark
Contacts
Primary ContactEva Lykke, MD
Backup ContactAnders Christensen, MD, PhD
Outcome results
None listed