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

Not Applicable

Completed

• Conditions: Thyroidectomy; Autofluorescence; Autotransplantation
• Interventions: Device: Fluobeam LX; Other: Conventional surgery without NIRAF assistance

• Registration Number: NCT05044351
• Lead Sponsor: Regional Hospital West Jutland

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-05
• Study First Submitted QC: 2021-09-05
• Study First Posted: 2021-09-14
• Study Start: 2021-09-15
• Primary Completion: 2023-09-16
• Study Completion: 2023-10-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(A): NIRAF-assisted surgery	Fluobeam LX	Patients undergoing NIRAF-assisted hemithyroidectomy
(B): Conventional surgery	Conventional surgery without NIRAF assistance	Patients undergoing conventional hemithyroidectomy without NIRAF-assistance

Primary Outcome Measures

Name	Time	Method
Parathyroid gland identification rate	Will be assessed at the time of surgery

Secondary Outcome Measures

Name	Time	Method
Rate of autotransplantation	Will be assessed at the time of surgery
Rate of inadvertent parathyroid excision	Will be assessed one month following surgery

Trial Locations

Locations (1)

Department of Otorhinolaryngology, Regional Hospital West Jutland; 🇩🇰 Holstebro, Denmark