Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Plus NIR optical imaging NIR optical imaging assisted identification of parathyroid glands during thyroid surgery |
Device: NIR optical imaging camera
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense
|
| No Intervention: Minus NIR optical imaging Conventional identification of parathyroid glands during thyroid surgery |
Outcome Measures
Primary Outcome Measures
- Postoperative hypoparathyroidism [24 months-follow-up]
Hypoparathyroidism defined as: PTH < 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline
Secondary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet | Copenhagen | Denmark | 2100 | |
| 2 | Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark | Køge | Denmark | 4600 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
- Cluster for molecular imaging, Denmark
- Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
Investigators
- Study Director: Christian von Buchwald, MDSc, PhD, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
- Abbaci M, De Leeuw F, Breuskin I, Casiraghi O, Lakhdar AB, Ghanem W, Laplace-Builhé C, Hartl D. Parathyroid gland management using optical technologies during thyroidectomy or parathyroidectomy: A systematic review. Oral Oncol. 2018 Dec;87:186-196. doi: 10.1016/j.oraloncology.2018.11.011. Epub 2018 Nov 16.
- Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6.
- Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31.
- H19010211