Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy? (FLUOB)

The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy

Study Overview

• Status: Completed
• Conditions: Thyroidectomy

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. Limitations of naked eye inspection and subjectivity of palpation are imposing challenges even for the most experienced surgeons. 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.

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. Moreover, the investigators are going to evaluate correlation of autofluorescence with 24 hours post-operative PTH.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54636
    • AHEPA University Hospital of Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Our sample size of 180 patients has been calculated after power analysis regarding other similar studies with an a=0.05 and Power=0.95.

Description

Inclusion Criteria:

• Patient is over 18 years old
• Patient scheduled for a non-emergency operation
• Patient eligible for total thyroidectomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Autofluorescence; The surgeon will perform the preplanned operation 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 operation without FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: Surgery date; Duration of surgery; Operation performed; Procedure related comments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy.	The aim of the study is to evaluate the use of autofluorescence to distinguish parathyroid glands during thyroidectomy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detecting the changes of practice in performing total thyroidectomy when monitoring parathyroids with autofluorescence.	If autofluorescence is proved to be a useful tool in endocrine surgeons hands, the preservation of parathyroid glands during thyroidectomy would be easier.	6 months
Comparing autofluorescence monitored minimal invasive total thyroidectomy with classic minimal invasive total thyroidectomy	To compare the duration and safety of minimal invasive thyroidectomy with or without FLUOBEAM XS	6 months
Correlating autofluorescence with 24 hours post-operative PTH.	This study aims to analyze statistically and prove the possible correlation of autofluorescence results with post-operative PTH	7 months
Identifying the cut-off points that predict low PTH levels (less than 20pg/ml)	After statistical analysis, we will try to find the cut-off point of PTH levels after autofluorescence results (if they are statistical significant correlated with post-operative PTH)	7 months
Identifying and analyzing problematic groups of patients	This study will sign out the disadvantages of FLUOBEAM XS or cases that its use should be avoided.	6 months

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Theodossis S Papavramidis, MD, PhD, AHEPA University Hospital of Thessaloniki, Greece

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): March 27, 2020
• Study Completion (Actual): March 27, 2020

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: thyroidectomy; autofluorescence; parathyroid glands; FLUOBEAM XS
• Other Study ID Numbers: FLUOB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No