Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions

Regional Hospital West Jutland

Status: Completed

Conditions: Autofluorescence; Hypocalcemia; Thyroidectomy; Hypoparathyroidism

Treatments: Device: Fluobeam LX, Fluoptics, Grenoble, France

Study type: Interventional

Funder types: Other

Identifiers

NCT05043584

Autofluorescence1.0

Details and patient eligibility

About

Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.

In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid institutions is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on immediate, transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid institutions.

Full description

Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX) at two low-volume ENT-departments with no experience in parathyroid surgery.

PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and minimum two months following surgery. Patients who still fulfill the criteria for hypoparathyroidism at that point will be followed until one year following surgery. The rates of immediate, transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred for total thyroidectomy
• Age > 18
• Able to understand patient information
• Able to give informed consent

Exclusion criteria

• Previous thyroid surgery
• Need for accelerated surgery
• Insufficient biochemical profile

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

(A): NIRAF-assisted surgery

Experimental group

Description:

Patients undergoing NIRAF-assisted total thyroidectomy

Treatment:

Device: Fluobeam LX, Fluoptics, Grenoble, France