Back to resultsNear-infrared Autofluorescence (NIRAF) in Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Centers
Primary Purpose
Autofluorescence, Thyroidectomy, Hypoparathyroidism
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fluobeam LX
Sponsored by
About this trial
This is an interventional prevention trial for Autofluorescence
Eligibility Criteria
Inclusion Criteria:
- Patients referred for total thyroidectomy
- Age > 18
- Able to understand patient information
- Able to give informed consent
Exclusion Criteria:
- Completion lobectomy
- Need for accelerated surgery
- Insufficient biochemical profile
Sites / Locations
- Department of Otorhinolaryngology, Hospital South West JutlandRecruiting
- Department of Otorhinolaryngology, Regional Hospital West JutlandRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
(A): NIRAF-assisted surgery
Arm Description
Patients undergoing NIRAF-assisted total thyroidectomy
Outcomes
Primary Outcome Measures
Rate of permanent hypoparathyroidism
Secondary Outcome Measures
Rate of transient hypoparathyroidism
Parathyroid identification rate
Autoimplantation rate
Rate of inadvertently excised parathyroid glands
Full Information
NCT ID
NCT05043584
First Posted
September 5, 2021
Last Updated
September 14, 2021
Sponsor
Regional Hospital West Jutland
Collaborators
Hospital of South West Jutland
1. Study Identification
Unique Protocol Identification Number
NCT05043584
Brief Title
Near-infrared Autofluorescence (NIRAF) in Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Centers
Official Title
Prevention of Postoperative Hypoparathyroidism Following Thyroid Surgery by Using Intraoperative Autofluorescence
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital West Jutland
Collaborators
Hospital of South West Jutland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.
In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid centers.
Detailed Description
Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX).
PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and 6 months following surgery. The rates of transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autofluorescence, Thyroidectomy, Hypoparathyroidism, Hypocalcemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
(A): NIRAF-assisted surgery
Arm Type
Experimental
Arm Description
Patients undergoing NIRAF-assisted total thyroidectomy
Intervention Type
Device
Intervention Name(s)
Fluobeam LX
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Rate of permanent hypoparathyroidism
Time Frame
Will be assessed one year following surgery
Secondary Outcome Measure Information:
Title
Rate of transient hypoparathyroidism
Time Frame
Will be assessed one year following surgery
Title
Parathyroid identification rate
Time Frame
Will be assessed at the time of surgery
Title
Autoimplantation rate
Time Frame
Will be assessed at the time of surgery
Title
Rate of inadvertently excised parathyroid glands
Time Frame
Will be assessed 1 month following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients referred for total thyroidectomy
Age > 18
Able to understand patient information
Able to give informed consent
Exclusion Criteria:
Completion lobectomy
Need for accelerated surgery
Insufficient biochemical profile
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Abood, MD
Phone
+45 7843 9744
Email
aliabo@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Therese Ovesen, MD, DMSc
Phone
+45 7843 9744
Email
theroves@rm.dk
Facility Information:
Facility Name
Department of Otorhinolaryngology, Hospital South West Jutland
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Bach, MD
Facility Name
Department of Otorhinolaryngology, Regional Hospital West Jutland
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Abood, MD
Phone
+45 7843 9744
Email
aliabo@rm.dk
First Name & Middle Initial & Last Name & Degree
Therese Ovesen, MD, DMSc
Phone
+4578439744
Email
theroves@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Near-infrared Autofluorescence (NIRAF) in Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Centers
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