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

Regional Hospital West Jutland

Status: Completed

Conditions: Autotransplantation; Autofluorescence; Thyroidectomy

Treatments: Device: Fluobeam LX; Other: Conventional surgery without NIRAF assistance

Study type: Interventional

Funder types: Other

Identifiers

NCT05044351

Autofluorescence2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

(A): NIRAF-assisted surgery

Experimental group

Description:

Patients undergoing NIRAF-assisted hemithyroidectomy

Treatment:

Device: Fluobeam LX

(B): Conventional surgery

Active Comparator group

Description:

Patients undergoing conventional hemithyroidectomy without NIRAF-assistance

Treatment:

Other: Conventional surgery without NIRAF assistance