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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05044351

Enrollment

170

Registered

2021-09-14

Start date

2021-09-15

Completion date

2023-10-16

Last updated

2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autofluorescence, Autotransplantation, Thyroidectomy

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.

Interventions

DEVICEFluobeam LX

See arm description

OTHERConventional surgery without NIRAF assistance

Patients undergoing conventional hemithyroidectomy without NIRAF-assistance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Masking description

Patients and related health care staff will be blinded for the allocated intervention until the day of surgery

Intervention model description

Randomized Clinical Trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Parathyroid gland identification rate	Will be assessed at the time of surgery

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026