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Completed

NCT Number: NCT05044351

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.

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Key information

Conditions

Autofluorescence Autotransplantation Thyroidectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otorhinolaryngology, Regional Hospital West Jutland

Holstebro, 7500, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluobeam LX

Device

See arm description

Conventional surgery without NIRAF assistance

Other

Patients undergoing conventional hemithyroidectomy without NIRAF-assistance

Primary outcomes

  1. Parathyroid gland identification rate

    Time frame: Will be assessed at the time of surgery

Secondary outcomes

  1. Rate of inadvertent parathyroid excision

    Time frame: Will be assessed one month following surgery

  2. Rate of autotransplantation

    Time frame: Will be assessed at the time of surgery

Sponsors and collaborators

Lead sponsor

Regional Hospital West Jutland

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2021
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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