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

December 31, 2023 updated by: Ali Abood, Regional Hospital West Jutland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6700
        • Department of Otorhinolaryngology, Hospital South West Jutland
      • Holstebro, Denmark, 7500
        • Department of Otorhinolaryngology, Regional Hospital West Jutland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (A): NIRAF-assisted surgery
Patients undergoing NIRAF-assisted total thyroidectomy
Device: Fluobeam LX, Fluoptics, Grenoble, France
See arm description

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital West Jutland

Collaborators

Hospital of South West Jutland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

September 5, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 31, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Autofluorescence1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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