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NCT Number: NCT05043584

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

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.

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Key information

Conditions

Autofluorescence Calcium Metabolism Disorders Endocrine System Diseases Hypocalcemia Hypoparathyroidism Metabolic Diseases Nutritional and Metabolic Diseases Parathyroid Diseases Thyroidectomy Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otorhinolaryngology, Hospital South West Jutland, Esbjerg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluobeam LX, Fluoptics, Grenoble, France

Device

See arm description

Primary outcomes

  1. Rate of hypoparathyroidism

    Time frame: Will be assessed on postoperative day one, minimum two months and one year following surgery.

Secondary outcomes

  1. Parathyroid gland identification rate

    Time frame: Will be assessed at the time of surgery

  2. Parathyroid autotransplantation rate

    Time frame: Will be assessed at the time of surgery

  3. Rate of inadvertently excised parathyroid glands

    Time frame: Will be assessed 1 month following surgery

Sponsors and collaborators

Lead sponsor

Regional Hospital West Jutland

Other

Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2021
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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