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NCT05043584 Clinical Trial

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

Hypoparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05043584
Other study ID # Autofluorescence1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2021
Est. completion date December 1, 2023

Study information
Verified date December 2023
Source Regional Hospital West Jutland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Fluobeam LX, Fluoptics, Grenoble, France
See arm description

Locations
Country Name City State
Denmark Department of Otorhinolaryngology, Hospital South West Jutland Esbjerg
Denmark Department of Otorhinolaryngology, Regional Hospital West Jutland Holstebro

Sponsors (2)
Lead Sponsor Collaborator
Regional Hospital West Jutland Hospital of South West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of hypoparathyroidism Will be assessed on postoperative day one, minimum two months and one year following surgery.
Secondary Parathyroid gland identification rate Will be assessed at the time of surgery
Secondary Parathyroid autotransplantation rate Will be assessed at the time of surgery
Secondary Rate of inadvertently excised parathyroid glands Will be assessed 1 month following surgery
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