Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery

Study Overview
=================
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: Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence. 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.

Official Title
-----------------
Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery Can Prevent Post-thyroidectomy Hypoparathyroidism

Conditions
-----------------
Hypoparathyroidism Postprocedural, Hypocalcemia, Surgery--Complications

Intervention / Treatment
-----------------
* Device: NIR optical imaging camera


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plus NIR optical imaging<br>NIR optical imaging assisted identification of parathyroid glands during thyroid surgery | Device: NIR optical imaging camera<br>* NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense<br>|
| No Intervention: Minus NIR optical imaging<br>Conventional identification of parathyroid glands during thyroid surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hypoparathyroidism | Hypoparathyroidism defined as: PTH < 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline | 24 months-follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hypocalcemia | Hypocalcemia defined as: ionized Calcium < 1,15 mmol/L | 12 months follow-up | 
| Time | Duration of surgery | Immediately after surgery | 
| Parathyroidglands identified by NIR light | Number of identified by NIR light vs. white light | During surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autofluorescense, thyroide surgery, total thyroidectomy, compltion thyroidectomy, parathyroidectomy, NIR, near-infrared, optical imaging