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

Study Overview
=================
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.

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

Conditions
-----------------
Autofluorescence, Thyroidectomy, Autotransplantation

Intervention / Treatment
-----------------
* Device: Fluobeam LX
* Other: Conventional surgery without NIRAF assistance


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (A): NIRAF-assisted surgery<br>Patients undergoing NIRAF-assisted hemithyroidectomy | Device: Fluobeam LX<br>* See arm description<br>|
| Active Comparator: (B): Conventional surgery<br>Patients undergoing conventional hemithyroidectomy without NIRAF-assistance | Other: Conventional surgery without NIRAF assistance<br>* Patients undergoing conventional hemithyroidectomy without NIRAF-assistance<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parathyroid gland identification rate |  | Will be assessed at the time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |