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

Last updated: November 7, 2023
Sponsor: Regional Hospital West Jutland
Overall Status: Completed

Phase

N/A

Condition

Ear, Nose, And Throat (Ent) Surgeries

Treatment

Conventional surgery without NIRAF assistance

Fluobeam LX

Clinical Study ID

NCT05044351
Autofluorescence2.0
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 170
Treatment Group(s): 2
Primary Treatment: Conventional surgery without NIRAF assistance
Phase:
Study Start date:
September 15, 2021
Estimated Completion Date:
October 16, 2023

Study 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.

Connect with a study center

  • Department of Otorhinolaryngology, Hospital South West Jutland

    Esbjerg, 6700
    Denmark

    Site Not Available

  • Department of Otorhinolaryngology, Regional Hospital West Jutland

    Holstebro, 7500
    Denmark

    Site Not Available

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