An observational study in Thyroidectomy, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-02.
Sponsored by Aristotle University Of Thessaloniki · Observational
The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy
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.
Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
The surgeon will perform the preplanned operation with FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: 1. Surgery date 2. Duration of surgery 3. Operation performed 4. Procedure related comments 5. Number and location of the visualized glands 6. Intra-operative autofluorescence score (either 0 (no visualization or 1 visualization) for each gland
The surgeon will perform the preplanned operation without FLUOBEAM XS. The following intraoperative variables will be recorded for all patients: 1. Surgery date 2. Duration of surgery 3. Operation performed 4. Procedure related comments
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
Time frame: 6 months
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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 6 months
Plan to share: Undecided
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Aristotle University Of Thessaloniki