Near-infrared Autofluorescence (NIRAF) in Thyroid Lobectomy: Impact in Low-volume, Non-parathyroid Centers

Overview

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 thyroid lobectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in low-volume, non-parathyroid centers.

Full Title of Study: “Prevention of Postoperative Hypoparathyroidism Following Thyroid Surgery by Using Intraoperative Autofluorescence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2023

Detailed Description

Patients referred for thyroid lobectomy will be randomized to either: (A) NIRAF-assisted surgery (Fluobeam LX) or (B) Conventional thyroid surgery. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and 2 months following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: (A): NIRAF-assisted surgery
    • Patients undergoing NIRAF-assisted thyroid lobectomy
  • Active Comparator: (B): Conventional surgery
    • Patients undergoing conventional thyroid surgery without NIRAF-assistance

Clinical Trial Outcome Measures

Primary Measures

  • Rate of inadvertent parathyroid excision
    • Time Frame: Will be assessed one month following surgery

Secondary Measures

  • Parathyroid identification rate
    • Time Frame: Will be assessed at the time of surgery
  • Rate of autotransplantation
    • Time Frame: Will be assessed at the time of surgery

Participating in This Clinical Trial

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 – Insufficient biochemical profile

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regional Hospital West Jutland
  • Collaborator
    • Hospital of South West Jutland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ali Abood, MD – Regional Hospital West Jutland
  • Overall Contact(s)
    • Ali Abood, MD, +4578439744, aliabo@rm.dk

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