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NCT05044351 Clinical Trial

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

Thyroidectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05044351
Other study ID # Autofluorescence2.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2021
Est. completion date October 16, 2023

Study information
Verified date November 2023
Source Regional Hospital West Jutland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date October 16, 2023
Est. primary completion date September 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Fluobeam LX
See arm description
Other:
• Conventional surgery without NIRAF assistance
Patients undergoing conventional hemithyroidectomy without NIRAF-assistance

Locations
Country Name City State
Denmark Department of Otorhinolaryngology, Regional Hospital West Jutland Holstebro

Sponsors (1)
Lead Sponsor Collaborator
Regional Hospital West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Parathyroid gland identification rate Will be assessed at the time of surgery
Secondary Rate of inadvertent parathyroid excision Will be assessed one month following surgery
Secondary Rate of autotransplantation Will be assessed at the time of surgery
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