Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 170
- Locations
- 2
- Primary Endpoint
- Parathyroid gland identification rate
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Masking Description
Patients and related health care staff will be blinded for the allocated intervention until the day of surgery
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Parathyroid gland identification rate
Time Frame: Will be assessed at the time of surgery
Secondary Outcomes
- Rate of autotransplantation(Will be assessed at the time of surgery)
- Rate of inadvertent parathyroid excision(Will be assessed one month following surgery)
Investigators
Ali Abood
MD
Regional Hospital West Jutland