Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy With Central Lymph Node Compartment Dissection

Overview

The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy with central lymph node compartment dissection.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 30, 2022

Detailed Description

Real-time intraoperative identification and functional maintenance of structures are of major importance in endocrine surgery, with a critical role in clinical outcomes and patients' quality of life. Despite the advances in preoperative imaging techniques, there is still need for precise intraoperative visualizing [1]. Limitations of naked eye inspection and subjectivity of palpation are imposing challenges even for the most experienced surgeons [1-3]. Nowadays, attention is attracted to intraoperative imaging techniques using Near Infrared Fluorescence (NIRF) with endogenous or exogenous contrast agents. These imaging techniques are attractive in biomedicine due to its high penetration depth and low scattering in human tissue [2]. Autofluorescence is the ability of several natural substances or drugs to be fluorescent after the absorbance of light or radiation. It has been already proved that parathyroid glands emit their own light after near-infrared (NIR) around 820nm , providing high contrast to the surrounding tissues. This made near-infrared autofluorescence a potential useful tool in hands of experienced endocrine surgeons in order to distinguish parathyroid glands from other anatomic structures during thyroidectomies. Approximately 7.6% of thyroid surgeries resulted in hypoparathyroidism, with 75% of these cases being transient and 25% being chronic. The mechanisms that underlie hypoPTH are related to disruption of parathyroid arterial supply or venous drainage, mechanical injury, thermal or electrical injury, and either intentional or inadvertent partial or complete removal. The aim of the present study is to evaluate the value of intra-operative autofluorescence imaging concerning the unintentional excision rate of parathyroids during total thyroidectomy with central lymph node compartment dissection. Moreover, we are going to evaluate correlation of autofluorescence with 24 hours post-operative PTH.

Arms, Groups and Cohorts

  • Autofluorescence
    • The surgeon will perform the preplanned thyroidectomy with central lymph node compartment dissection with FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: Surgery date Duration of surgery Operation performed Procedure related comments Number and location of the visualized glands Intra-operative autofluorescence score (either 0 (no visualization or 1 visualization) for each gland
  • Control
    • The surgeon will perform the preplanned thyroidectomy with central lymph node compartment dissection without autofluorescence device. The following intraoperative variables will be recorded for all patients: Surgery date Duration of surgery Operation performed Procedure related comments Number and location of the visualized glands

Clinical Trial Outcome Measures

Primary Measures

  • The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy with central lymph node dissection
    • Time Frame: 6 months
    • The aim of the study is to evaluate the use of autofluorescence to distinguish parathyroid glands during thyroidectomy with central lymph node dissection (TTCC). We will measure the number of parathyroids accidentally excised during TTCC with and without autofluorescence.

Secondary Measures

  • Detecting the changes of practice in performing total thyroidectomywith central lymph node dissection when monitoring parathyroids with autofluorescence.
    • Time Frame: 6 months
    • If autofluorescence is proved to be a useful tool in endocrine surgeons hands, the preservation of parathyroid glands during thyroidectomy with central lymph node dissection would be easier.
  • Correlating autofluorescence with 24 hours post-operative PTH.
    • Time Frame: 6 months
    • To identify any correlation between intra-operative parathyroid glands autofluorescence with postoperative hypoparathyroidism. We are going to evaluate the number of parathyroids evaluated and we are going to correlate it with PTH.
  • Correlating autofluorescence with postoperative hypocalcemia
    • Time Frame: 7months
    • To identify any correlation between intra-operative parathyroid glands autofluorescence with postoperative hypoparathyroidism. We are going to evaluate the number of parathyroids evaluated and we are going to correlate it with Ca.
  • Identifying and analyzing problematic groups of patients
    • Time Frame: 7 months
    • This study will sign out the disadvantages of FLUOBEAM XS or cases that its use should be avoided.

Participating in This Clinical Trial

Inclusion Criteria

1. Patient is over 18 years old 2. Patient scheduled for a non-emergency operation 3. Patient eligible for total thyroidectomy Exclusion Criteria:

1. Patient is participating in another clinical trial which may affect this study's outcomes 2. Prior operation in the neck 3. Primary or secondary hyperparathyroidism 4. Vitamin D deficiency 5. Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Aristotle University Of Thessaloniki
  • Collaborator
    • Umraniye Education and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Papavramidis Theodossis, Assistant Professor of Surgery – Aristotle University Of Thessaloniki
  • Overall Official(s)
    • Theodossis Papavramidis, MD, PhD, Principal Investigator, AHEPA University Hospital of Thessaloniki, Greece
  • Overall Contact(s)
    • Theodossis Papavramidis, MD, PhD, +306944536972, papavramidis@hotmail.com

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