Clinical trial NCT04193332: Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
Official title: Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery Can Prevent Post-thyroidectomy Hypoparathyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoparathyroidism Postprocedural
Hypocalcemia
Surgery--Complications
Keywords: thyroide surgery
total thyroidectomy
compltion thyroidectomy
parathyroidectomy
autofluorescense
NIR
near-infrared
optical imaging
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Cluster for molecular imaging, Denmark
name: Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
First posted: 2019-12-10
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Postoperative hypoparathyroidism
timeFrame: 24 months-follow-up
Secondary outcomes:
measure: Postoperative hypocalcemia
timeFrame: 12 months follow-up
measure: Time
timeFrame: Immediately after surgery
measure: Parathyroidglands identified by NIR light
timeFrame: During surgery
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Køge
country: Denmark
facility: Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
Study officials:
affiliation: Rigshospitalet, Denmark
name: Christian von Buchwald, MDSc, PhD
role: STUDY_DIRECTOR
References:
citation: Abbaci M, De Leeuw F, Breuskin I, Casiraghi O, Lakhdar AB, Ghanem W, Laplace-Builhe 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.
citation: 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.
citation: 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.