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

Not Applicable

Completed

• Conditions: Thyroidectomy; Autofluorescence; Hypoparathyroidism; Hypocalcemia
• Interventions: Device: Fluobeam LX, Fluoptics, Grenoble, France

• Registration Number: NCT05043584
• Lead Sponsor: Regional Hospital West Jutland

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.

Study Timeline

• Study First Submitted: 2021-09-05
• Study First Submitted QC: 2021-09-05
• Study First Posted: 2021-09-14
• Study Start: 2021-09-15
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Last Update Submitted: 2023-12-31
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(A): NIRAF-assisted surgery	Fluobeam LX, Fluoptics, Grenoble, France	Patients undergoing NIRAF-assisted total thyroidectomy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Department of Otorhinolaryngology, Hospital South West Jutland; 🇩🇰 Esbjerg, Denmark

Department of Otorhinolaryngology, Regional Hospital West Jutland; 🇩🇰 Holstebro, Denmark