Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy?

Completed

• Conditions: Thyroidectomy

• Registration Number: NCT04204317
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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

• Study First Submitted: 2019-12-03
• Study Start: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Primary Completion: 2020-03-27
• Study Completion: 2020-03-27
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AHEPA University Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece