NCT05044351

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Regional Hospital West Jutland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Autofluorescence
• Thyroidectomy
• Autotransplantation

Interventions

Type	Name	Description
DEVICE	Fluobeam LX	See arm description
OTHER	Conventional surgery without NIRAF assistance	Patients undergoing conventional hemithyroidectomy without NIRAF-assistance

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-09-16
• Completion: 2023-10-16
• First posted: 2021-09-14
• Last updated: 2023-11-09

Locations

1 site across 1 country: Denmark