Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy?

Thyroidectomy Clinical Trial

— FLUOB  

Official title:

Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204317
• Other study ID #: FLUOB
• Status: Completed
• Start date: December 17, 2019
• Est. completion date: March 27, 2020

Study information

• Verified date: April 2020
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 27, 2020
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Thyroidectomy

Locations

Country	Name	City	State
Greece	AHEPA University Hospital of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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