Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial

Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation.

In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed:

Aim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.

Study Overview

• Status: Completed
• Conditions: Thyroidectomy; Autofluorescence; Autotransplantation
• Intervention / Treatment: Device: Fluobeam LX; Other: Conventional surgery without NIRAF assistance

Detailed Description

Patients referred for hemithyroidectomy will be randomized to either:

(A) NIRAF-assisted hemithyroidectomy (Fluobeam LX) or (B) Conventional hemithyroidectomy. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and one month following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients referred for thyroid lobectomy
• Age > 18
• Able to understand patient information
• Able to give informed consent

Exclusion Criteria:

• Completion lobectomy
• Need for accelerated surgery
• Age < 18
• Unable to understand patient information
• Unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (A): NIRAF-assisted surgery; Patients undergoing NIRAF-assisted hemithyroidectomy	Device: Fluobeam LX; See arm description
Active Comparator: (B): Conventional surgery; Patients undergoing conventional hemithyroidectomy without NIRAF-assistance	Other: Conventional surgery without NIRAF assistance; Patients undergoing conventional hemithyroidectomy without NIRAF-assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parathyroid gland identification rate	Will be assessed at the time of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of inadvertent parathyroid excision	Will be assessed one month following surgery
Rate of autotransplantation	Will be assessed at the time of surgery

Collaborators and Investigators

• Sponsor: Regional Hospital West Jutland
• Collaborators: Hospital of South West Jutland

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): September 16, 2023
• Study Completion (Actual): October 16, 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 (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Autofluorescence2.0

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