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

Autofluorescence-guided Thyroid Surgery: Impact on Parathyroid Preservation and Hypoparathyroidism

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05043584

Enrollment

Registered

2021-09-14

Start date

2021-09-15

Completion date

2023-12-01

Last updated

2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autofluorescence, Hypocalcemia, Hypoparathyroidism, Thyroidectomy

Brief summary

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.

Detailed 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.

Interventions

DEVICEFluobeam LX, Fluoptics, Grenoble, France

See arm description

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Prospective cohort study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Rate of hypoparathyroidism	Will be assessed on postoperative day one, minimum two months and one year following surgery.

Secondary

Measure	Time frame
Parathyroid gland identification rate	Will be assessed at the time of surgery
Parathyroid autotransplantation rate	Will be assessed at the time of surgery
Rate of inadvertently excised parathyroid glands	Will be assessed 1 month following surgery

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026