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

NCT05043584 | Completed

• 1 other identifier: Autofluorescence1.0
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Autofluorescence; Thyroidectomy; Hypoparathyroidism; Hypocalcemia

Outcome Measures

Primary Outcomes (1)

• Rate of hypoparathyroidism

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

Secondary Outcomes (3)

• 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

Study Arms (1)

(A): NIRAF-assisted surgery

EXPERIMENTAL

Patients undergoing NIRAF-assisted total thyroidectomy

Device: Fluobeam LX, Fluoptics, Grenoble, France

Interventions

Fluobeam LX, Fluoptics, Grenoble, France DEVICE

See arm description

(A): NIRAF-assisted surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Regional Hospital West Jutland: lead
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator

Study Sites (2)

Department of Otorhinolaryngology, Hospital South West Jutland

Esbjerg, 6700, Denmark

Location

Department of Otorhinolaryngology, Regional Hospital West Jutland

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Hypoparathyroidism; Hypocalcemia

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: September 15, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)